#US similar biotherapeutics products market

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Biosimilars Unleashed: The Future of Healthcare in the US

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What is the Size of US Biosimilar Industry?

US Biosimilar Market is expected to grow at a CAGR of ~ % between 2017-2022 and is expected to reach ~USD Bn by 2028. Biosimilars enhance patient access to essential treatments, especially in therapies with high demand, like oncology, by providing more affordable options. Additionally, Growing evidence of biosimilars' comparable efficacy and safety fosters trust among healthcare professionals, driving adoption.

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Biosimilars offer cost savings compared to originator biologics, addressing the need for affordable healthcare solutions in the face of rising medical costs. Favorable regulatory frameworks, like the BPCIA, streamline biosimilar approval processes, encouraging manufacturers to invest in development.

Furthermore, The expiration of patents for numerous reference biologics creates opportunities for biosimilar entry, leading to increased competition and market expansion. Pharmaceutical companies are investing in biosimilar R&D and production, expanding the pipeline and market availability. Supportive healthcare policies and reimbursement models incentivize biosimilar adoption, creating a favorable environment for market growth.

US Biosimilar Market by drug class

The US Biosimilar market is segmented by Monoclonal Antibodies, Recombinant Hormones, Immunomodulators, Anti-inflammatory agents and Others. Based on drug class, Monoclonal Antibodies segment dominates the bio similar market in 2022.

Monoclonal antibodies have diverse applications across various therapeutic areas. From cancer treatment to autoimmune diseases, biosimilar Mabs addressed a wide range of medical needs, leading to a broad and growing market. Biosimilars, with their potential for cost savings while maintaining comparable efficacy and safety, gained significant attention as viable alternatives.

US Biosimilar Market by application

In US Biosimilar market, they are segmented by application into Oncology, Blood disorders, Chronic diseases and autoimmune conditions and Others. On the basis of application, Oncology segment was the dominant in 2022.

The increasing prevalence of cancer and the high cost of traditional biologics used in oncology treatment have created a strong incentive for the adoption of biosimilars. Biosimilars offer the potential to provide similar therapeutic outcomes at a lower cost, making them an attractive option for both healthcare providers and patients.

Additionally, the rigorous clinical trials and regulatory processes that biosimilars undergo to gain approval provide reassurance to healthcare professionals and patients regarding their safety and efficacy. This has led to increased acceptance and adoption of biosimilars in oncology.

US Biosimilar by Region

The US Biosimilar market is segmented by Region into North, East, West and South. In 2022, the dominance region is North region in US Biosimilar market.

The North region benefits from a concentration of healthcare providers and academic institutions that are at the forefront of adopting and integrating biosimilars into their treatment protocols. These institutions are more likely to have the expertise to evaluate and incorporate biosimilars effectively, driving their adoption among healthcare professionals and patients.

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Competition Scenario in US Biosimilar Market

The US biosimilar market has witnessed an evolving competitive landscape, with several key players competing for market share. Prominent pharmaceutical companies such as Amgen, Pfizer, Sandoz (Novartis), and Boehringer Ingelheim have been actively involved in developing and marketing biosimilar products. These established players have utilized their expertise in biologics and significant resources to navigate the regulatory landscape and compete effectively.

The competition in the US biosimilar market is characterized by a balance between established pharmaceutical giants and emerging biotech companies. While the major players possess the advantage of resources and experience, smaller biotech firms are also contributing to the market with innovative approaches and niche biosimilar offerings.

What is the Expected Future Outlook for the Overall US Biosimilar Market?

The US Biosimilar market was valued at USD ~Million in 2022 and is anticipated to reach USD ~ Billion by the end of 2028, witnessing a CAGR of ~% during the forecast period 2022- 2028. The US biosimilar market is likely to experience significant growth in the coming years, driven by several factors. Biosimilars are biologic drugs that are highly similar to already approved reference biologics. They offer potential cost savings, increased competition, and improved patient access to crucial treatments.

Firstly, the regulatory environment is becoming more favorable for biosimilars. The Biologics Price Competition and Innovation Act (BPCIA) established a pathway for biosimilar approval in the US, allowing for a smoother regulatory process. As more biosimilars receive approval, competition in the market is expected to intensify.

Secondly, patents for several blockbuster biologics are expiring or have already expired. This creates opportunities for biosimilar manufacturers to enter the market with more affordable alternatives, offering healthcare systems and patients a choice in treatment options.

Thirdly, as healthcare costs continue to rise, biosimilars present an attractive solution for reducing expenses. Their potential to offer cost savings without compromising therapeutic efficacy could lead to increased adoption by healthcare providers, insurers, and patients alike.

Physician and patient education are crucial, as misconceptions about biosimilars' safety and effectiveness might hinder their adoption. Additionally, legal and market access barriers, including patent litigation and complex distribution systems, could slow down the growth of the biosimilar market.

The biosimilar market witness consolidation as larger pharmaceutical companies acquire or partner with smaller biotech firms to bolster their biosimilar portfolios. This will lead to more resources being devoted to biosimilar development and marketing. Changes in healthcare policies, such as reimbursement models and value-based care initiatives, can influence the biosimilar market's growth. Favourable policies that incentivize biosimilar adoption drives their market growth.

[veedacr]

Global Oncology Biosimilar Market

Global Oncology Biosimilar Treatment Market – Past, present, and way forward

Biosimilar or biogenerics are biotherapeutic products with large and complex structures that are similar to their innovator product in all aspects including their safety, efficacy, and quality.

There is a palpable sense of urgency among researchers and pharmaceutical industries to develop biosimilar for treatment, with its popularity expected to rise in the forthcoming years especially in developing low-cost biosimilar that is easily accessible and affordable for patients.

Market trends show that North America continues to dominate the global oncology biosimilar market followed by Europe, Asia Pacific, Latin America, Middle East, and Africa. The market is purported to reach approximately USD 45 Billion in the year 2026 from the current market of approximately USD 6 Billion.

Understanding the local and global market demand is necessary for companies, research institutes, and investors to study the changing dynamics in the biosimilar market. Segmentation of biosimilar by product, type of cancer, as well as targeted end-user such as hospital/online/retail pharmacies is particularly useful in empowering industries to make informed business decisions. Product segmentation also helps gauge the project’s feasibility so that the pharmaceutical industry can focus on developing safe and commercially viable products. Comprehensive analyses, robust legal and regulatory frameworks, continuing medical education for health care professionals and increased awareness among the public will undoubtedly increase the uptake of biosimilar and help the biosimilar market move ahead competitively.

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Biosimilars Market Demand, Size, Share, Scope & Forecast to 2030

The Global Biosimilar Market is expected to be valued at USD 159.02 Billion by 2030 from USD 15.6 Billion in 2021, at a CAGR of 23.5% during the forecast period of 2021 to 2030.

Medicines known as biologics or biological products are created using living organisms through extremely intricate production procedures. They must be handled and administered under strict supervision. The term "biologics" refers to a broad range of goods, including vaccines, therapeutic proteins, monoclonal antibodies, and cell and gene therapies. Biologics are used to prevent, treat, or cure a number of illnesses, such as cancer, diabetes, cystic fibrosis, chronic kidney disease, and autoimmune disorders. Biologics are at the cutting edge of scientific and biological research and may be able to treat a variety of illnesses for which there are no other effective treatments.

A biotherapeutic product that is extremely similar to a reference biologic medication is referred to as a biosimilar, also known as a follow-on biologic. It has a complicated molecular structure and is made from living things or cells. Manufacturers rely on regulatory authority authorisation to launch the production of biosimilars when the patent on a biologic medication expires. A biological medication must be demonstrated to be identical in terms of quality, safety, and efficacy in order to be labelled as a biosimilar. Biosimilars are more expensive than generic medications because their production needs greater investment in R&D and is more complicated.

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Global Biosimilar Market: Segment Analysis

Biosimilar Market segment based on Molecule

• Filgrastim

• Rituximab

Filgrastim injection is for the treatment of Neutropenia, that is low white blood cells in the body, which is caused by cancer medicines. It is a synthetic form of substance that is produced naturally in your body known as colony stimulating factor. Filgrastim helps the bone marrow in the body to make new white blood cells itself.

Rituximab is used to treat certain types of Cancer such as Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Lukemia. It slows or stops the growth of cancer cells. Some products of Rituximab are also used to treat the pain of Rheumatoid Arthritis and can also decrease swelling and pain of the joints.

Segmentation based on Indication Insights

Oncology

Female Infertility

Oncology is the largest segment in this market due to the availability of Biosimilar at a lower price than Innovation Biologics and a large number of cancer patients. The availability of Biosimilar in Oncology has reduced the prices and made cancer treatment more accessible and affordable. Due to the high prevalence of cancer, healthcare systems across the globe are more concentrated on reducing the burden of cancer by adopting cost effective treatment options.

Biologics are too expensive and cannot be afforded by everyone. Therefore, cost-effective and new Biosimilars are being manufactured in the market. In January 2016, Teva Pharmaceutical Industries Ltd. introduced Ovaleap, a biosimilar to GONAL-f (follitropin alfa) from Merck KGaA. The low cost of Biosimilars promotes patient trust and boosts the market growth.

Segmentation based on Manufacturing

Contract Manufacturing

In- house Manufacturing

Based on the type of manufacturing, the market is classified into in-house manufacturing and contract manufacturing. Amongst these, in-house manufacturing holds the majority of the market share.

Top Key Players:-

LG Life Sciences

Fresenius SE & Co. KGaA

Pfizer, Inc.

Hospira

STADA Arzneimittel AG

Dr. Reddy’s Laboratories Ltd.

Eli Lilly and Company

Genentech (Roche Group).

Synthon Pharmaceuticals, Inc.

Celltrion

Boehringer Ingelheim

Amgen, Inc.

Gedeon Richter PLC

Merck Serono (Merck Group)

Teva Pharmaceutical Industries Ltd.

Biocon Limited

Samsung Biologics

Biogen idec, Inc.

Coherus BioSciences

Viatris, Inc

Fujifilm Kyowa Kirin Biologics Co., Ltd.

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Frequently Asked Questions (FAQ):

What is the impact of COVID-19 on the biosimilars market?

Who are the key players in the biosimilars market?

Which product segment dominates in the biosimilars market?

Which indication segment of the global biosimilars market is expected to witness the highest growth?

What is the market size for biosimilars market?

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Global Oncology Biosimilar Market

Global Oncology Biosimilar Treatment Market – Past, present, and way forward

Biosimilar or biogenerics are biotherapeutic products with large and complex structures that are similar to their innovator product in all aspects including their safety, efficacy, and quality.

There is a palpable sense of urgency among researchers and pharmaceutical industries to develop biosimilar for treatment, with its popularity expected to rise in the forthcoming years especially in developing low-cost biosimilar that is easily accessible and affordable for patients.

Market trends show that North America continues to dominate the global oncology biosimilar market followed by Europe, Asia Pacific, Latin America, Middle East, and Africa. The market is purported to reach approximately USD 45 Billion in the year 2026 from the current market of approximately USD 6 Billion.

Understanding the local and global market demand is necessary for companies, research institutes, and investors to study the changing dynamics in the biosimilar market. Segmentation of biosimilar by product, type of cancer, as well as targeted end-user such as hospital/online/retail pharmacies is particularly useful in empowering industries to make informed business decisions. Product segmentation also helps gauge the project’s feasibility so that the pharmaceutical industry can focus on developing safe and commercially viable products. Comprehensive analyses, robust legal and regulatory frameworks, continuing medical education for health care professionals and increased awareness among the public will undoubtedly increase the uptake of biosimilar and help the biosimilar market move ahead competitively

[elizasanchez]

Chromatography Resins Market (2020-2027) - Growth, Trends, COVID-19 Impact, and Forecasts

The global chromatography resins market is projected to be worth USD 3,269.9 Million by 2027, according to a current analysis by Emergen Research. The chromatography resin market observes high demand attributed to its rising application in the drug development process as biotherapeutic development advances have produced a wide range of complex molecules, posing complex purification challenges. Affinity or liquid chromatographic technology has garnered immense significance as a preferred method of separation in pharmaceutical, biotechnology, biochemistry, and environmental science. The technology is primarily a more precise and efficient method for protein purification.

The evaluation of the companies involves assessment of production and consumption ratio, supply and demand, import/export, market share and size, revenue contribution, gross revenue, profit margins, and key business expansion strategies. Other vital information such as mergers and acquisitions, collaborations, joint ventures, government and corporate deals, agreements, and product launches, and brand promotional activities are also assessed in the report. Moreover, it also offers strategic recommendations to the new entrants on navigating the entry-level barriers along with recommendations for established players to help them fortify their positions in the industry.

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Key Highlights From The Report

·         In October 2019, Danaher entered into an agreement with Sartorius Stedim Biotech to divest its three life sciences tools businesses for worth about USD 750.0 million. As per the agreement, Sartorius would acquire chromatography hardware & resins, label-free biomolecular characterization, and microcarriers & particle validation standards businesses of Danaher.

·         The market in the Asia Pacific region is projected to grow at the fastest rate of 8.6% in the forecast period attributed to a growing emphasis on developing generic drugs and the growth of the food & beverage industry.

·         Key participants include Thermo Fisher Scientific Inc., WR Grace & Co., Danaher Corporation, Merck KGaA, GE Healthcare, Bio-Rad Laboratories Inc., Purolite Corporation, Tosoh Corporation, Mitsubishi Chemical Corporation, and Kaneka Corporation, among others.

Emergen Research has segmented the global chromatography resins market on the basis of type, technology, application, and region:

·         Type Outlook (Revenue, USD Billion; 2017-2027)

o    Natural

o    Synthetic

o    Inorganic Media

·         Technology Outlook (Revenue, USD Billion; 2017-2027)

o    Ion Exchange

o    Hydrophobic Interaction

o    Affinity

o    Size Exclusion

o    Multimodal

o    Others

·         Application Outlook (Revenue, USD Billion; 2017-2027)

o    Pharmaceutical

1.      Biotechnology

2.      Drug Discovery

3.      Drug Production

o    Food & Beverage

o    Water & Environmental Agencies

o    Others

Regional Bifurcation includes:

•        North America(U.S., Canada)

•        Europe(U.K., Italy, Germany, France, Rest of EU)

•        AsiaPacific(India, Japan, China, South Korea, Australia, Rest of APAC)

•        Latin America(Chile, Brazil, Argentina, Rest of Latin America)

•        Middle East & Africa(Saudi Arabia, U.A.E., South Africa, Rest of MEA)

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Key inferences influencing the revenue patterns of the market:

·         The study offers an in-depth analysis of the product outlook, which depicts the latest production growth trends and profit valuation. It further fragments the global Chromatography Resins market into a wide product spectrum.

·         The study covers essential data pertaining to the application landscape of these products, the demand for and market share held by each application type, along with their growth rate analysis over the estimated period.

·         A meticulous description of the distribution channels, including distributors, producers, and buyers, is one of the key highlights of the global Chromatography Resins market report.

Table of Content:

Chapter 1. Methodology & Sources     1.1. Market Definition     1.2. Research Scope     1.3. Methodology     1.4. Research Sources           1.4.1. Primary           1.4.2. Secondary           1.4.3. Paid Sources     1.5. Market Estimation Technique Chapter 2. Executive Summary     2.1. Summary Snapshot, 2019-2027 Chapter 3. Key Insights Chapter 4. Chromatography Resins Market Segmentation & Impact Analysis     4.1. Chromatography Resins Market Material Segmentation Analysis     4.2. Industrial Outlook           4.2.1. Market indicators analysis           4.2.2. Market drivers analysis                     4.2.2.1. Surging demand in drug development process                     4.2.2.2. Growing demand for green chromatography                     4.2.2.3. Growing usage of separation methods in the food & beverage industry                     4.2.2.4. Increased investment in R&D           4.2.3. Market restraints analysis                     4.2.3.1. Lack of skilled personnel     4.3. Technological Insights     4.4. Regulatory Framework     4.5. Porter’s Five Forces Analysis     4.6. Competitive Metric Space Analysis     4.7. Price trend Analysis     4.8. Covid-19 Impact Analysis

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ANTIBODIES MARKET ANALYSIS - (2019-2027)

Antibodies are used in therapeutic application for the treatment of diseases such as cancer, autoimmune diseases, hematological diseases, infectious diseases, and others. Increasing prevalence of cancer is expected to create lucrative opportunities for growth of manufacturers in the market. For instance, according to the National Cancer Institute, 2016, the number of new cancer cases per year is expected to increase to 23.6 million by 2030, worldwide. Antibodies products come under biologic therapeutic products. Biologic manufacturers require approval (similar to pharma drug approval) from the U.S. Food & Drug Administration prior to bringing the product in the market. However, unlike drugs, biologics require Biologics License Applications (BLA) to be filed with the Center for Biologics Evaluation and Research (CBER). Moreover, various government authorities are focused on controlling/lowering drug prices by adding reforms. For instance, the U.S. government is seeking to lower patients out-of-pocket spending in Medicare by curbing deals that drug manufacturers make with its distribution channel partners such as pharmacy benefit managers, February 2019 (these deals are responsible for increasing list price of drugs).

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Restraints of the Global Antibodies Market

High cost of monoclonal antibodies therapies makes it unaffordable for the population in the low- and middle-income group to opt for these therapies, which in turn restrains growth of the market. For instance, Keytruda (Pembrolizumab), a monoclonal antibody for the treatment of various types of cancer, costs around US$ 2,250 for a vial of 50 mg.

Key features of the study:

This report provides in-depth analysis of the global Antibodies Market and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period (2019–2027), considering 2018, as the base year

It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market

This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategy adopted by leading players

It profiles leading players in the global antibodies market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, strategies, and future plans

Key companies covered as a part of this study include Novartis AG, F. Hoffmann-La Roche Ltd., Johnson & Johnson Services, Inc., Takeda Pharmaceutical Company Limited, Amgen Inc., Biogen Inc., Bristol-Myers Squibb Company, AbbVie Inc., Sanofi, Eli Lilly and Co., Iovance Biotherapeutics, Inc., Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd.

Insights from this report would allow marketers and the management authorities of companies to make informed decision regarding future product launches, technology up-gradation, market expansion, and marketing tactics

The global Antibodies Market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.

Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the market.

Detailed Segmentation

Global Antibodies Market, By Product Type:

Monoclonal antibodies

Polyclonal antibodies

Antibody-drug complexes (ADCs)

Global Antibodies Market, By Disease Indication:

CNS Disorders

Cardiovascular Diseases

Cancer

Autoimmune Disorders

Global Antibodies Market, By End User:

Hospitals

Long-term Care Facilities

Research institutes

Global Antibodies Market, By Geography:

North America

By Product Type

Monoclonal antibodies

Polyclonal antibodies

Antibody-drug complexes (ADCs)

Disease Indication

CNS Disorders

Cardiovascular Diseases

Cancer

Autoimmune Disorders

By End User

Hospitals

Long-term Care Facilities

Research institutes

By Country:

U.S.

Canada

Europe

By Product Type

Monoclonal antibodies

Polyclonal antibodies

Antibody-drug complexes (ADCs)

Disease Indication

CNS Disorders

Cardiovascular Diseases

Cancer

Autoimmune Disorders

By End User

Hospitals

Long-term Care Facilities

Research institutes

By Country:

U.K.

Germany

Italy

France

Spain

Russia

Rest of Europe

Asia Pacific

By Product Type

Monoclonal antibodies

Polyclonal antibodies

Antibody-drug complexes (ADCs)

Disease Indication

CNS Disorders

Cardiovascular Diseases

Cancer

Autoimmune Disorders

By End User

Hospitals

Long-term Care Facilities

Research institutes

By Country:

China

India

Japan

ASEAN

Australia

South Korea

Rest of Asia Pacific

Latin America

By Product Type

Monoclonal antibodies

Polyclonal antibodies

Antibody-drug complexes (ADCs)

Disease Indication

CNS Disorders

Cardiovascular Diseases

Cancer

Autoimmune Disorders

By End User

Hospitals

Long-term Care Facilities

Research institutes

By Country:

Brazil

Mexico

Argentina

Rest of Latin America

Middle East:

By Product Type

Monoclonal antibodies

Polyclonal antibodies

Antibody-drug complexes (ADCs)

Disease Indication

CNS Disorders

Cardiovascular Diseases

Cancer

Autoimmune Disorders

By End User

Hospitals

Long-term Care Facilities

Research institutes

By Country:

GCC

Israel

Rest of Middle East

Africa

By Product Type

Monoclonal antibodies

Polyclonal antibodies

Antibody-drug complexes (ADCs)

Disease Indication

CNS Disorders

Cardiovascular Diseases

Cancer

Autoimmune Disorders

By End User

Hospitals

Long-term Care Facilities

Research institutes

By Country/Region:

Central Africa

South Africa

North Africa

Company Profiles

Novartis International AG*

Company Overview

Product Portfolio

Financial Performance

Key Strategies

Recent Developments

F. Hoffmann-La Roche Ltd.

Johnson & Johnson Services, Inc.

Takeda Pharmaceutical Company Limited

Amgen Inc.

Biogen Inc.

Bristol-Myers Squibb Company

AbbVie Inc.

Sanofi S.A.

Eli Lilly and Co.

Iovance Biotherapeutics, Inc.

Ultragenyx Pharmaceutical Inc.

Kyowa Kirin Co., Ltd.

“*” marked represents similar segmentation in other categories in the respective section.

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ANTIBODIES MARKET ANALYSIS by Coherent Market Insights

Antibodies Market To Surpass US$ 384.0 Billion By 2027 - Coherent Market Insights

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Antibody, also called as immunoglobulin, is a protein produced by plasma cells in response to specific antigens. These antibodies can be used as therapeutic as well as diagnostic purposes for several indications, including cancers, autoimmune disorders, inflammatory & infectious diseases and others.

The global antibodies market is estimated to account for US$ 147,385.1 Mn in terms of value and is expected to reach US$ 384,011.6 Mn by the end of 2027.

Global Antibodies Market: Drivers

Therapeutic monoclonal antibodies find wide application in oncology, neurobiology, autoimmunology, and cardiology. Increasing prevalence of chronic disease is expected to propel growth of the global antibodies market. For instance, according to the World Health Organization, around 18.1 million new cases and 9.6 million deaths were registered due to cancer worldwide in 2018.

Moreover, availability of inexpensive biosimilar antibody therapeutics is also expected to aid in growth of the market. For instance, in December 2019, the World Health Organization (WHO) prequalified its first biosimilar medicine – trastuzumab –– a monoclonal antibody for the treatment of early stage breast cancer. On an average trastuzumab costs US$ 20,000. However, the biosimilar version of trastuzumab is generally 65% cheaper than the originator.

North America region held dominant position in the global antibodies market in 2018, accounting for 44.5% share in terms of value, followed by Europe.

Global Antibodies Market: Restraints

High cost of therapeutic antibodies is expected to hamper growth of the global antibodies market. For instance, in the U.S., the monthly treatment cost for rheumatoid arthritis with Humira is over US$ 5,500.

Use of antibodies may lead to some side effects such as serum sickness, acute anaphylaxis, and specific target-related adverse effects, which is also expected to hinder the market growth.

Global Antibodies Market: Opportunities

The patent of several blockbuster antibody products is set to expire in the near future. Therefore, key players in the market can focus on launching biosimilar antibodies to enhance their market share.

Moreover, evolution of clear regulatory approval process for biosimilars in emerging markets represents additional opportunity for antibody-based products. For instance, in 2012, Central Drugs Standard Control Organization, Gov. of India released regulatory requirements for marketing approval of similar biologics in India, which was revised in 2016 for more clarity. According to the revision, the reference biologic may be approved or marketed either in India or any other International Council for Harmonization countries.

Drug type segment in the global antibodies market was valued at US$ 131,472.4 in 2018 and is expected to reach US$ 384,011.6 by 2027 at a CAGR of 12.5% during the forecast period.

Market Trends/Key Takeaways

The adoption of antibody-based drugs for the treatment of cancer has significantly increased. Monoclonal antibody therapeutics offer high specificity, activity, favorable pharmacokinetics, and standardized manufacturing processes. Moreover, antibodies can increase immune response against cancer cells through complement-dependent cytotoxicity or antibody dependent cellular cytotoxicity.

The use of antibodies as a diagnostic reagents for the identification of disease markers or proteins based on immunoassays has decreased. This is attributed to increasing accuracy of molecular diagnostic tools.

Regulations:

North America

U.S.

Therapeutic antibodies are the biological products which are regulated by both the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER)

Therapeutic antibody products (including monoclonal antibody, antibody drug conjugates, Fc fragment proteins) are subject to submission of biologics license application (BLA)

Manufacturers of therapeutic antibody products thus needed to submit BLA to CBER or CDER under 21 CFR 601.2, which contains safety, purity and potency data from clinical and non-clinical laboratory studies and other manufacturing information

Whereas, diagnostic antibodies are classified under in vitro diagnostic device (IVD) as Analyte Specific Reagents (ASR) and thus subject to regulations under 21CFR864.4020

Diagnostic antibodies which are used in immunological testing of infectious diseases are classified as Class II IVDs whereas antibodies used for diagnosis of highly contagious diseases such as HIV, TB are classified as Class III IVDs, both of which require to obtain premarket approval under section  510 (k) of  S. federal food drug and cosmetics (FD&C) act

In U.S., biosimilar biologics product approval is submitted to FDA under section 351(k) of the Public Health Service Act

Global Antibodies Market: Competitive Landscape

Major players operating in the global antibodies market include, Novartis AG, F. Hoffmann-La Roche Ltd., Johnson & Johnson Services, Inc., Takeda Pharmaceutical Company Limited, Amgen Inc., Biogen Inc., Bristol-Myers Squibb Company, AbbVie Inc., Sanofi, Eli Lilly and Co., Iovance Biotherapeutics, Inc., Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd.

Global Antibodies Market: Key Developments

Key players in the market are focused on adopting partnership and collaboration strategies to expand their product portfolio. For instance, in January 2020, MorphoSys AG collaborated with Incyte Corporation for development and commercialization of MorphoSys’ tafasitamab, a humanized Fc-engineered monoclonal antibody against CD19.

Similarly, in January 2020, Ligand Pharmaceuticals Inc. entered into a license agreement with Pandion Therapeutics, under which the later will use Ligand’s OmniAb antibody discovery platform in exchange of an up-front platform access fee, development and regulatory milestone payments, and potential royalties on sales of marketed products.

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“*” marked represents similar segmentation in other categories in the respective section.

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[biotechtimes]

Report points to bright future for biologics and biosimilars

New Post has been published on https://biotechtimes.org/2019/11/22/report-points-to-bright-future-for-biologics-and-biosimilars/

Report points to bright future for biologics and biosimilars

By Sunderarajan Padmanabhan

New Delhi, November 22: Biologics and biosimilars could be the next rising stars in biotechnology with a new review by the Department of Biotechnology finding that the market size of the segment could grow at a compounded annual rate (CAGR) of 22 percent in the coming years to reach US dollars 12 billion by 2025.

The pharmaceutical industry is currently facing many changes both within India and globally. Small molecule therapeutics had till recently dominated research and accounted for a major share of the pharma market as they had several inherent advantages such as a tendency to be chemically and thermally stable, ability to access targets in intracellular regions and a simpler drug discovery and development process, besides being suitable for oral delivery.

However, biologics and biosimilars, which are larger molecule therapeutics have recently taken a lead over them as they were better in terms of targeted delivery and had substantially lower side effects in areas such as cancer treatments. They are increasingly becoming the treatment of choice.

Biologics are basically products that are produced from living organisms or contain components of living organisms. They include a wide variety of products derived from humans, animals or microorganisms using the tools of biotechnology. Follow-on biologics and biosimilars as a class of drugs have emerged as an effective alternative to reduce the cost of biologic therapies.

A biosimilar is a biotherapeutic product that is almost similar to an already licensed biotherapeutic in terms of quality, safety and efficacy, except for some minor differences modifications. Follow-on biologics, in turn, are nothing but biotherapeutics, whose patent has expired.

A report on the new review released as part of the ongoing international meet on biotechnology – Global Bio India 2019, noted that the Indian pharmaceutical industry in the country was well geared to take advantage of the emerging situation.

It has pointed out that while globally, 1015 biosimilars/ follow-up biologics are under development for various therapy areas such as rheumatoid arthritis, neutropenia and cancer by 475 companies, in India 201 active biosimilars were in the pipeline of 52 domestic pharmaceutical companies.

It also noted that product patents of more than 10 blockbuster biologics with total revenue of US dollar 60 billion are set to expire within two to three years thus offering a further potential boost to the biosimilars market.

The report was prepared in collaboration with the Department of Biotechnology’s Biotechnology Industry Research Assistance Council, Association of Biotechnology Led Enterprises,  a not-for-profit pan-India forum that represents the Indian Biotechnology Sector, and Cortellis, a global firm that specializes in providing insights into various aspects of life science research. Union Minister for Science and Technology, Earth Sciences, and Health and Family Welfare, Dr. Harsh Vardhan, released it. (India Science Wire).

[kenresearch1]

Top 5 players in US Biosimilar Market

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STORY OUTLINE

Pfizer: Excelling in the line of Biosimilar drugs with an experience of more than 10 years with presence in over 180 countries.

Amgen: Making pharmaceutical products with an experience of over 40 years and presence in over 100 countries.

Viartis: Presence in over 165 countries, and making Biosimilar drugs in over 75 markets, this pharmaceutical company is another leading contributor of US Biosimilar market.

Coherus Biosciences: Increasing patient access to cost effective medicines with a Biosimilar drugs experience of 13 years.

Biogen: serving humanity through science with a experiences of more than 40 years in the field of biologics.

According to Ken Research, the US Biosimilar market is anticipated to grow at a CAGR of ~40% in the next five years which currently has a market size of ~USD 9.4 Bn.

The US Biosimilar market is rapidly growing and will be witnessing a significant growth in the next five years.

There are various reasons behind the rapid growth of US Biosimilar market. Some of the major reasons behind the growth of US Biosimilar market include the cost effective nature of Biosimilar drugs, rising geriatric population, rising prevalence of chronic diseases, and growing partnerships between companies to develop Biosimilar drugs.

Various companies and players are contributing to their best efforts in the growth of the US Biosimilar market.

This article aims to put light on the contributions done by the major players towards the growth of the US Biosimilar market.

1.Pfizer

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Pfizer is a leading American pharmaceutical company which is operating in the field of generics or original drugs for more than 30 years. But did you know that this pharma not only manufactures biologics but also biosimilar drugs?

Pfizer has been in the business of biosimilar drugs for more than 10 years and have been quite successful as well. With more than 83,000 employees and presence in over 180 countries, this leading pharmaceutical company made almost USD 2 Bn. revenue only from its Biosimilar drugs sale in 2021.

Recently, this pharmaceutical company also collaborated with Samsung in two deals to produce various biosimilar drugs in South Korea. The deal size between these two companies happens to be approximately USD 900 Bn.

The major Biosimilar drugs of this pharmaceutical giant are primarily

ZIRABEV (a Biosimilar of Avastin)

TRAZIMERA (a Biosimilar of Herceptin)

RUXIENCE (a Biosimilar of Rituxan)

RITACRIT (a Biosimilar of Epogen)

NVYEPRIA (a Biosimilar of Neulasta)

NIVESTYM (a Biosimilar of Neupogen)

FILGRASTIM (a Biosimilar of Neupogen).

2.Amgen

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Amgen is another leading American pharmaceutical company which not only makes Biologics or generic drugs but also Biosimilar drugs. This pharmaceutical company has more than 40 years of experience when it comes to pharmaceutical line.

With over 25000 employees and presence in over 100 countries, this pharmaceutical company earned about USD 2 Bn. from their three biosimilar drugs which are reportedly MVASI, KANJITNTI, and AMJEVITA.

This pharma giant has also invested about USD 2 Bn. in the development of Biosimilar drugs.

This pharmaceutical company has made Biosimilar drugs primarily in 4 fields which are General Medicine, Oncology, and Hematology along with, Inflammation.

EPOTEIN ALFA

AMJEVITA

AVSOLA

KANJINTI

MVASI

RIABNI

are the various Biosimilar drugs of Amgen. And, STELARA, EYLEA, SOLIRIS are in their pipeline.

Recently Amgen revealed their Biosimilar report’s 8 version. It revealed a major information which said that the pharmaceutical company saved about USD 10 Bn. through their Biosimilar drugs in the past five years.

3.Viartis

Headquartered in Canonsburg, Pennsylvania, this American pharmaceutical company was founded only in 2020 yet they have achieved massive success in the pharmaceutical products with their revenue being USD 16 ~Bn. in 2022.

With presence in 165 countries and with over 45,000 employees worldwide, this pharmaceutical company makes pharmaceutical products in 10 areas which primarily are Cardiovascular, Dermatology, ophthalmology, Oncology, Gastroenterology, Women’s health, Infectious diseases, Diabetes & Metabolism, Immunology, CNS & Anesthesiology, Respiratory diseases and allergy.

Speaking of their first Biosimilar products, their first ever Biosimilar drug was launched in 2014. They have a variety of Biosimilar drugs which are primarily

TRASTUZUMAB

INSULIN ASPART

PEGFILGRASTIM

INSULIN GLARGINE-YFGN

ADALIMUMAB

BEVACIZUMAB

Their Biosimilar drug Insulin Glargine which is known as SEMGLEE was the first ever interchangeable Biosimilar drug in the United States which was FDA approved.

Their PEGFILGRASTIM also was the first ever FDA approved drug in the United States. They have launched their Biosimilar drugs in over 75 markets worldwide.

4.Coherus Biosciences:

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Headquartered in Redwood city, California this American pharmaceutical company earned a revenue of almost USD 211 Mn. In 2022.

With presence in over 55 countries and 300+ employees worldwide, this pharmaceutical company makes products in various areas such as solid tumors, non-small lung cancers, nasopharyngeal carcinoma, small cell lung cancer and hepatocellular carcinoma.

Speaking of their Biosimilar drugs, this pharma has been in the field of creating Biosimilar drugs since 2010 which has given them almost 13 years of experience.

This pharmaceutical company also disclosed that it plans to spend at least USD 1 Tn. on medicines worldwide, out of which at least 40% will be spent on Biosimilar drugs.

Their three major Biosimilar drugs which are also FDA approved include UDENCYA, YUSIMRY, and CIMERLI.

Udencya is a Biosimilar drug of Pegfilgrastim, Yusimry is a Biosimilar drug of Ranibizumab, and Cimerli is a Biosimilar drug of Adalimumab.

5.Biogen

Headquartered in Cambridge, Massachusetts, this American pharmaceutical company earned a revenue of around USD 10 Bn. in 2022.

This company happens to have an experience of more than 40 years when it comes to making pharmaceutical products.

With presence in over 80 countries and more than 9000 employees worldwide, this pharmaceutical company primarily deals in Neurology, Specialized Immunology, Neuropsychiatry, Ophthalmology, and Rare Diseases.

ADUCANUMAB

LECANEMAB

TOFERSEN

ZURANOLONE

LITIFILIMAB

BENAPALI

FLIXABI

IMRALDI

are some of their Biosimilar drugs.

With their Biosimilar drugs, more than 250,000 people have gone on Anti-Tumor Necrosis Factor therapy.

Recently, this pharmaceutical company also made an agreement with Bio-Thera solutions to develop a Biosimilar drug for the treatment of Rheumatoid Arthritis.

[mikemortgage]

Daiichi Sankyo Selects Lead Candidate Built on Zymeworks’ Azymetric™ Bispecific Platform

One of three bispecific immuno-oncology therapeutics being developed under the two companies’ collaboration agreements

Zymeworks to receive US$3.5 million commercial license payment from Daiichi Sankyo

VANCOUVER, British Columbia VANCOUVER, British Columbia & TOKYO & BASKING RIDGE, N.J. — Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, and Daiichi Sankyo Company, Limited (“Daiichi Sankyo”) announced today that Daiichi Sankyo has exercised its option for a commercial license to a proprietary immuno-oncology bispecific built on Zymeworks’ Azymetric™ and EFECT™ platforms. Zymeworks will receive a US$3.5 million payment based on Daiichi Sankyo’s selection of the first of up to three lead product candidates under its collaboration agreements with Zymeworks.

“This is another example of how our Azymetric platform can facilitate the rapid selection and development of bispecific antibody candidates for our pharmaceutical partners,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “We are thrilled to see Daiichi Sankyo move this novel therapeutic program into late-stage preclinical development. This is an important step forward towards our shared goal of improving the standard of care for patients with cancer.”

“Our partnership with Zymeworks has allowed us to develop therapeutic candidates based on complex mechanisms of action such as immune cell engagement,” said Antoine Yver, M.D., M.Sc., Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “Through this partnership, we have identified a novel bispecific therapeutic that we are excited to be advancing towards the clinic. We look forward to continuing our strong partnership with Zymeworks to develop novel therapeutic options for patients with cancer worldwide.”

Under the terms of the 2016 cross-licensing and collaboration agreement, Zymeworks granted Daiichi Sankyo a license to Zymeworks’ Azymetric™ and EFECT™ platforms to develop a bispecific antibody therapeutic for which Zymeworks is eligible to receive further clinical and commercial milestone payments of up to US$143.4 million, as well as up to double-digit tiered royalties on global product sales. Additionally, Zymeworks obtained a license to certain immuno-oncology antibodies from Daiichi Sankyo, with the right to research, develop, and commercialize multiple bispecific products globally in exchange for royalties on global product sales.

About the Azymetric™ Platform

The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life, and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development costs and timelines.

About the EFECT™ Platform

The EFECT platform is a library of antibody Fc modifications engineered to modulate the activity of the antibody-mediated immune response, which includes both the up- and down-regulation of effector functions. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization of therapeutic responses for different diseases.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. The Company’s suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks’ lead clinical candidate, ZW25, is a novel Azymetric™ bispecific antibody currently in Phase 2 clinical development. The Company’s second clinical candidate, ZW49, is a bispecific antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of ZW25 with Zymeworks’ proprietary ZymeLink™ cytotoxic payload. Zymeworks is also advancing a deep preclinical pipeline in immuno-oncology and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through multiple strategic partnerships with eight global biopharmaceutical companies. For more information, visit www.zymeworks.com.

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: [fam-] trastuzumab deruxtecan, an antibody drug conjugate (ADC) for HER2 expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/refractory FLT3-ITD acute myeloid leukemia (AML); and pexidartinib, an oral CSF1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com.

Zymeworks Cautionary Note Regarding Zymeworks’ Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements that relate to future development activities in accordance with the terms of Zymeworks’ agreements with Daiichi Sankyo, potential payments and/or royalties payable to Zymeworks under these agreements, the speed and outcome of drug development plans, Zymeworks’ potential global growth, and other information that is not historical information. When used herein, words and phrases such as “enable”, “will”, “may”, “eligible to”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Annual Report on Form 10-K for its year ended December 31, 2018 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Contacts

Daiichi Sankyo Jennifer Brennan (908) 992 6631 (office) (201) 709 9309 (mobile) jbrennan2@dsi.com

Zymeworks Inc. Investor Inquiries: Ryan Dercho, Ph.D. (604) 678-1388 ir@zymeworks.com Tiffany Tolmie (604) 678-1388 ir@zymeworks.com Media Inquiries: Angela Bitting (925) 202-6211 a.bitting@comcast.net

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[martynnx-blog]

Remicade Biosimilars Market Top-Vendor And Industry Analysis By End-User Segments Till 2026

Biosimilar refers to biotherapeutic product that is similar in terms of quality, efficacy, and safety to an existing licensed reference therapeutic drug. Biological products are the fastest growing class of therapeutic products, as they offer additional treatment options and help in lowering healthcare costs. Biosimilars are almost identical copies of the originally approved drugs and can be manufactured only when the patent for the original innovator drug expires. These products are highly sensitive to smallest changes in manufacturing procedure, as these drugs possess high molecular complexity. Remicade (Infliximab) refers to a chimeric monoclonal antibody biologic licensed by U.S. FDA in 1998, as an innovative product indicated for the treatment of Crohn’s disease in adults and children.

The monoclonal antibody drug was first developed in partnership by Janssen Biotech, Inc. and Merck & Co. The Remicade was later approved for its use in the treatment of ulcerative colitis, plague psoriasis, rheumatic arthritis, and spinal psoriatic arthritis in combination with methotrexate. Later, various pharmaceutical manufacturers developed biosimilars to infliximab, which lowered market share of Remicade due to cost-effective prices.

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Regional Insights

On the basis of region, the global Remicade biosimilar market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Europe holds a dominant position in the global Remicade biosimilar market and is expected to retain its dominance over the forecast period, owing to the presence of top market players in the region, rapid entry of biosimilars in the European market as well as high adoption rate due low price of the biosimilars. For instance, in 2018, Sandoz, a Novartis division received European Commission (EC) approval for Zessly (infliximab) a remicade biosimilar for use in Europe. The successive research and speedy approvals by the U.S. regulatory authorities for market entry of biosimilars in North America is expected to drive growth of the market over the forecast period. For instance, in December 2017, Pfizer, Inc. received the U.S. FDA approval for second biosimilar, Ifixi to Janssen’s blockbuster drug Remicade to treat rheumatoid arthritis.

Furthermore, Asia Pacific is expected to witness significant growth in the market over the forecast period, owing to developments in healthcare infrastructure and U.S. FDA approval of Remicade (infliximab) biosimilars by regional players to market the products internationally. For instance, in April 2016, Celltrion- a South Korea-based manufacturing company received the U.S. FDA approval for intravenously administered version of the rheumatoid arthritis drug sold under the name Infllectra. Moreover, major investments by regional players for research and development of biosimilar production is expected to drive growth of the market in Asia. For instance, in October 2016, Cipla, Inc. invested US$ 8 million to set up a manufacturing plant for biosimilars in South Africa.

Competitive Landscape

Key players operating in the global remicade biosimilar market include Janssen Biotech, Inc., Merck and Company, Inc., Alvogen, Pfizer, Inc., Celltrion, Nippon Kayaku, Napp Pharmaceuticals, and others.

[healthcare00897]

Remicade Biosimilars Market is forecasted to witness a thriving growth by 2026

Biosimilar refers to biotherapeutic product that is similar in terms of quality, efficacy, and safety to an existing licensed reference therapeutic drug. Biological products are the fastest growing class of therapeutic products, as they offer additional treatment options and help in lowering healthcare costs. Biosimilars are almost identical copies of the originally approved drugs and can be manufactured only when the patent for the original innovator drug expires. These products are highly sensitive to smallest changes in manufacturing procedure, as these drugs possess high molecular complexity. Remicade (Infliximab) refers to a chimeric monoclonal antibody biologic licensed by U.S. FDA in 1998, as an innovative product indicated for the treatment of Crohn’s disease in adults and children.

The monoclonal antibody drug was first developed in partnership by Janssen Biotech, Inc. and Merck & Co. The Remicade was later approved for its use in the treatment of ulcerative colitis, plague psoriasis, rheumatic arthritis, and spinal psoriatic arthritis in combination with methotrexate. Later, various pharmaceutical manufacturers developed biosimilars to infliximab, which lowered market share of Remicade due to cost-effective prices.

Market Dynamics:

Increasing incidence of autoimmune diseases such as plaque psoriasis and rheumatoid arthritis are expected to drive growth of the Remicade biosimilar market size. According to the American Autoimmune Related Disease Association, around 50 million American suffered from autoimmune diseases in the U.S. in 2017. Moreover, faster reaction rates of these biosimilars due to their availability in the form of intravenous mode of administration is further expected to increase the adoption of Remicade biosimilar over the forecast period. Furthermore, patent expiry of the branded versions is expected to increase the number of biosimilars for its branded counterparts thereby increasing the demand for Remicade biosimilar. However, stringent regulatory guidelines for development of these biosimilars as well as side effects of these drugs leading to risk of hospitalization are expected to restrain growth of the global Remicade biosimilar market.

Regional Insights

On the basis of region, the global Remicade biosimilar market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Europe holds a dominant position in the global Remicade biosimilar market and is expected to retain its dominance over the forecast period, owing to the presence of top market players in the region, rapid entry of biosimilars in the European market as well as high adoption rate due low price of the biosimilars. For instance, in 2018, Sandoz, a Novartis division received European Commission (EC) approval for Zessly (infliximab) a remicade biosimilar for use in Europe. The successive research and speedy approvals by the U.S. regulatory authorities for market entry of biosimilars in North America is expected to drive growth of the market over the forecast period. For instance, in December 2017, Pfizer, Inc. received the U.S. FDA approval for second biosimilar, Ifixi to Janssen’s blockbuster drug Remicade to treat rheumatoid arthritis.

Furthermore, Asia Pacific is expected to witness significant growth in the market over the forecast period, owing to developments in healthcare infrastructure and U.S. FDA approval of Remicade (infliximab) biosimilars by regional players to market the products internationally. For instance, in April 2016, Celltrion- a South Korea-based manufacturing company received the U.S. FDA approval for intravenously administered version of the rheumatoid arthritis drug sold under the name Infllectra. Moreover, major investments by regional players for research and development of biosimilar production is expected to drive growth of the market in Asia. For instance, in October 2016, Cipla, Inc. invested US$ 8 million to set up a manufacturing plant for biosimilars in South Africa.

Competitive Landscape

Key players operating in the global remicade biosimilar market include Janssen Biotech, Inc., Merck and Company, Inc., Alvogen, Pfizer, Inc., Celltrion, Nippon Kayaku, Napp Pharmaceuticals, and others. Market players are focused on introducing maximum number of biosimilar for multiple indications to retain their position in the global market. For instance, in July 2017, Merck & Company, Inc. in collaboration with Samsung Bioepis introduced Renflexis (infliximab-abda), a biosimilar to Remicade for the treatment of moderate to severe Crohn’s disease, active ulcerative colitis, rheumatoid arthritis, and other few disease indications.

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Market Taxonomy

On the basis of disease indication, the global Remicade biosimilars market is segmented into:

   Ulcerative Colitis

   Rheumatoid Arthritis

   Ankylosing Spondylitis

   Crohn’s Disease

   Psoriatic Arthritis

   Plaque Psoriasis

On the basis of geography, the global Remicade biosimilars market is segmented into:

   North America

   Latin America

   Europe

   Asia Pacific

   Middle East

   Africa

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[jamesgeiiger]

Zymeworks Highlights 2018 Achievements and Announces 2019 Priorities

VANCOUVER, Canada — Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reviewed its key 2018 accomplishments and outlined the Company’s priorities for 2019.

“With our clinical, preclinical, and business development achievements in 2018, along with a robust balance sheet, we believe we are in a strong position to continue delivering on our corporate objectives in 2019 and beyond,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “Our priorities include aggressively advancing our clinical and preclinical programs and continuing the development of our therapeutic platforms, which not only underpin our in-house pipeline but have also served as the basis of eight major pharmaceutical partnerships. We remain committed to our mission of creating novel biotherapeutics that allow patients worldwide to return home to their loved ones, disease free.”

2018 Achievements

Presented Expanded ZW25 Data, Underscoring its Anti-Tumor Activity and Tolerability Zymeworks reported clinical results for ZW25, a novel Azymetric™ bispecific HER2-targeting antibody, at multiple medical meetings. Data continues to demonstrate ZW25’s robust single-agent anti-tumor activity and tolerability in heavily pretreated patients across a variety of HER2-expressing cancers.

ZW49 Investigational New Drug (IND) Application Accepted by the FDA ZW49, Zymeworks’ second clinical candidate, is a novel bispecific HER2-targeting antibody drug conjugate. IND-enabling studies demonstrated promising efficacy and tolerability, suggesting a wide therapeutic window.

New Corporate Partnerships Established and Existing Ones Expanded Zymeworks entered into new collaborations with BeiGene, which includes a licensing agreement in the Asia Pacific region (excluding Japan) for ZW25 and ZW49, and with LEO Pharma, which expands Zymeworks’ pipeline into new disease areas. The Company also expanded its existing collaborations with Daiichi Sankyo and Celgene. Zymeworks currently has eight active collaborations that offer up to US$7.6 billion in potential milestone payments plus royalties.

Drug Candidate from First Corporate Partnership Poised to Enter Clinical Studies Eli Lilly submitted an IND application for one of its bispecific antibodies enabled by Zymeworks’ Azymetric platform resulting in a milestone payment to the Company.

Introduced Robust Immune Oncology (IO) Preclinical Pipeline Zymeworks unveiled a number of IO programs showcasing the versatility of its platform technologies. Leveraging the Azymetric platform, Zymeworks showed how optimizing bispecific geometry and formats can maximize activity, potentially creating new classes of precision therapeutics.

Expanded Executive Leadership Team Tony Polverino, Ph.D., joined Zymeworks as Executive VP of Early Development and CSO. In this newly created role, he oversees the Company’s R&D strategy and advances product candidates from discovery through translational research/early development.

Built Strong Balance Sheet Zymeworks completed a US$97.8 million public financing and added non-dilutive capital from its corporate partnerships totaling US$89 million in 2018.

2019 Corporate Priorities

Zymeworks will focus on achieving the following in 2019:

Initiating multiple Phase 2 studies for ZW25

Expanding the global clinical development of ZW25 into Asia and Europe

Reporting ZW25 data from combination studies (chemotherapy and/or targeted agents)

Reporting data from the Phase 1 trial for ZW49

Establishing additional drug development collaborations with a focus on new platforms

In addition, Zymeworks expects its pharmaceutical partners to continue nominating new Azymetric bispecific antibody therapeutic candidates for clinical development in 2019.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of next-generation multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel Azymetric™ bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. The Company’s second clinical candidate, ZW49, capitalizes on the unique design and antibody framework of ZW25 and is a bispecific antibody-drug conjugate, armed with the Company’s proprietary ZymeLink™ cytotoxic payload. Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in immune oncology and other therapeutic areas. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through multiple strategic partnerships with global biopharmaceutical companies.

Cautionary Note Regarding Forward Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include statements that relate to Zymeworks’ anticipated achievement of corporate milestones in 2019, expected clinical results and preclinical data, the nature and progress of Zymeworks’ current and projected corporate partnerships, its strategies for the development of ZW25 and ZW49, and other information that is not historical information. When used herein, words such as “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions, including assumptions regarding anticipated reporting of additional clinical and preclinical data, the efficacy of ZW25, ZW49 and the Azymetric platform and Zymeworks’ ability to enter into new partnership arrangements. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its fiscal quarter ended September 30, 2018 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. You should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance, or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events, except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190106005068/en/

Contacts

Investors: Ryan Dercho, Ph.D. (604) 678-1388 ir@zymeworks.com

Media: Angela Bitting (925) 202-6211 a.bitting@comcast.net

Zymeworks Highlights 2018 Achievements and Announces 2019 Priorities published first on https://worldwideinvestforum.tumblr.com/

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Remicade Biosimilars Market - Size, Share, Growth and Outlook, Analysis, 2018-2026

Biosimilar refers to biotherapeutic product that is similar in terms of quality, efficacy, and safety to an existing licensed reference therapeutic drug. Biological products are the fastest growing class of therapeutic products, as they offer additional treatment options and help in lowering healthcare costs. Biosimilars are almost identical copies of the originally approved drugs and can be manufactured only when the patent for the original innovator drug expires. These products are highly sensitive to smallest changes in manufacturing procedure, as these drugs possess high molecular complexity. Remicade (Infliximab) refers to a chimeric monoclonal antibody biologic licensed by U.S. FDA in 1998, as an innovative product indicated for the treatment of Crohn’s disease in adults and children. The monoclonal antibody drug was first developed in partnership by Janssen Biotech, Inc. and Merck & Co. The Remicade was later approved for its use in the treatment of ulcerative colitis, plague psoriasis, rheumatic arthritis, and spinal psoriatic arthritis in combination with methotrexate. Later, various pharmaceutical manufacturers developed biosimilars to infliximab, which lowered market share of Remicade due to cost-effective prices.

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Market Dynamics

Increasing incidence of autoimmune diseases such as plaque psoriasis and rheumatoid arthritis are expected to drive growth of the Remicade biosimilar market size. According to the American Autoimmune Related Disease Association, around 50 million American suffered from autoimmune diseases in the U.S. in 2017. Moreover, faster reaction rates of these biosimilars due to their availability in the form of intravenous mode of administration is further expected to increase the adoption of Remicade biosimilar over the forecast period. Furthermore, patent expiry of the branded versions is expected to increase the number of biosimilars for its branded counterparts thereby increasing the demand for Remicade biosimilar. However, stringent regulatory guidelines for development of these biosimilars as well as side effects of these drugs leading to risk of hospitalization are expected to restrain growth of the global Remicade biosimilar market.

Regional Insights

On the basis of region, the global Remicade biosimilar market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Europe holds a dominant position in the global Remicade biosimilar market and is expected to retain its dominance over the forecast period, owing to the presence of top market players in the region, rapid entry of biosimilars in the European market as well as high adoption rate due low price of the biosimilars. For instance, in 2018, Sandoz, a Novartis division received European Commission (EC) approval for Zessly (infliximab) a remicade biosimilar for use in Europe. The successive research and speedy approvals by the U.S. regulatory authorities for market entry of biosimilars in North America is expected to drive growth of the market over the forecast period. For instance, in December 2017, Pfizer, Inc. received the U.S. FDA approval for second biosimilar, Ifixi to Janssen’s blockbuster drug Remicade to treat rheumatoid arthritis.

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Competitive Landscape

Key players operating in the global remicade biosimilar market include Janssen Biotech, Inc., Merck and Company, Inc., Alvogen, Pfizer, Inc., Celltrion, Nippon Kayaku, Napp Pharmaceuticals, and others. Market players are focused on introducing maximum number of biosimilar for multiple indications to retain their position in the global market. For instance, in July 2017, Merck & Company, Inc. in collaboration with Samsung Bioepis introduced Renflexis (infliximab-abda), a biosimilar to Remicade for the treatment of moderate to severe Crohn’s disease, active ulcerative colitis, rheumatoid arthritis, and other few disease indications.

Market Taxonomy

On the basis of disease indication, the global Remicade biosimilars market is segmented into: Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Psoriatic Arthritis, Plaque Psoriasis,.

On the basis of geography, the global Remicade biosimilars market is segmented into: North America, Latin America, Europe, Asia Pacific, Middle East, Africa,.

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Global Oncology Biosimilars Market with Rising Demand & Huge Application Potential from Industry by 2026

A new business intelligence report released by Data Bridge Market Research with title Global Oncology Biosimilars Market are taken from trustworthy sources such as websites, annual reports of the companies, journals, and others and were checked and validated by the market experts. Oncology Biosimilars market research report provides estimation and analysis of the rising trends along with major drivers, restraints, challenges and opportunities in the  industry. Besides, Oncology Biosimilars  report systematically gathers the information about influencing factors for the industry which contains customer behavior, emerging trends, product usage, and brand positioning. This Oncology Biosimilars report brings into light several information about the industry that display important facts and figures, expert opinions, and the most recent developments across the sphere. By applying business intelligence, the report is organized which provides thorough and extensive market insights. Some of the key players profiled in the study Amgen Inc, Pfizer Inc, Eli Lilly and Company, Novartis AG, F. Hoffmann-La Roche Ltd, Eisai Co., Ltd, Allergan, Teva Pharmaceutical Industries Ltd, Bristol-Myers Squibb Company and more.

Global oncology biosimilars market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market is growing at a healthy CAGR in the above-mentioned research forecast period. Emerging markets and huge investment in research and development are the factors responsible for the growth of this market.

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Unlock new opportunities in Oncology Biosimilars Market; the latest release from Data Bridge Market Research highlights the key market trends significant to the growth prospects, Let us know if any specific players or list of players needs to consider to gain better insights.

Competition Analysis:

The major players covered in the global oncology biosimilars market are Amgen Inc, Pfizer Inc, Eli Lilly and Company, Novartis AG, F. Hoffmann-La Roche Ltd, Eisai Co., Ltd, Allergan, Teva Pharmaceutical Industries Ltd, Bristol-Myers Squibb Company, Takeda Pharmaceutical Company Limited, Endo International plc, Sun Pharmaceutical Industries Ltd, Mylan N.V., Apotex Inc, Biocad, and others.

 Research Methodology

This research study involves the extensive usage of secondary sources, directories, and databases (such as Hoovers, Bloomberg, Businessweek, Factiva, and OneSource) to identify and collect information useful for this technical, market-oriented, and commercial study of the global Oncology Biosimilars market. In-depth interviews were conducted with various primary respondents, which include key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information, and assess future market prospects. The following figure shows the market research methodology applied in making this report on the global Oncology Biosimilars market.

Global Oncology Biosimilars Market Scope and Market Size

Oncology biosimilars market is segmented on the basis of indication, drug class, route of administration end-users and distribution channel.

On     the basis of indication, the global oncology biosimilars market is     segmented into breast cancer, lung cancer, colorectal cancer,     cervical cancer, blood cancer and others.

Based     on drug class, the global oncology biosimilars market is segmented into     monoclonal antibodies, granulocyte colony-stimulating factor and others.

Route     of administration segment for global oncology biosimilars market is     categorized into intravenous, subcutaneous and others.

On     the basis of end-users, the global oncology biosimilars market is     segmented into hospitals, homecare, specialty clinics and others.

On     the basis of distribution channel, the global oncology biosimilars market     has been bifurcated into hospital pharmacy, online pharmacy and retail     pharmacy.

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Global Oncology Biosimilars Market Dynamics:

Global Oncology Biosimilars Market, By Indication (Breast Cancer, Lung Cancer, Colorectal Cancer, Cervical Cancer, Blood Cancer, Others), Drug Class (Monoclonal Antibodies, Granulocyte Colony-Stimulating Factor, Others), Route of Administration (Intravenous, Subcutaneous, Others), End-Users (Hospitals, Homecare, Specialty Clinics, Others), Distribution Channel (Hospital Pharmacy, Online Pharmacy, Retail Pharmacy), Country (U.S., Canada, Mexico, Brazil, Argentina, Peru, Rest of South America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Hungary, Lithuania, Austria, Ireland, Norway, Poland, Rest of Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Vietnam, Rest of Asia-Pacific, Saudi Arabia, U.A.E, Egypt, Israel, Kuwait, South Africa, Rest of Middle East and Africa) Industry Trends and Forecast to 2027

Market Drivers:

The growth of oncology biosimilars market enhanced by the growing cases of cancer such as lung cancer and breast cancer, vulnerable aging population and rise in research and development activities conducted by many pharmaceuticals’ companies. In addition, increase patient awareness level, advances in the treatment options and high cost of biologics drugs are some of the impacting factors for the demand of oncology biosimilars. Nevertheless, product recalls coupled with stringent regulations are the factors that hinder the growth of this market.

A biosimilar product describes as biotherapeutics that’s highly similar to the biological product or reference product. Also, biosimilars product has to be no clinically meaningful differences between the two products. The biosimilars which are employed for the treatment of cancer is termed as oncology biosimilars.       

The Oncology Biosimilars report puts light on the change in the market which is taking place due to the moves of key players and brands such as product launches, joint ventures, mergers and acquisitions that in turn modifies the view of the global face of industry. This market report takes into account myriad of aspects of the market analysis which today’s businesses call for. To make the report outstanding, most up-to-date and advanced tools and techniques are used so that client achieves maximum benefits. The Oncology Biosimilars report also includes the market drivers and market restraints that are derived from SWOT analysis.

Chapters to deeply display the Global Oncology Biosimilars market.

Introduction about Oncology Biosimilars

Oncology Biosimilars Market Size (Sales) Market Share by Type (Product Category) in 2019

Oncology Biosimilars Market by Application/End Users

Oncology Biosimilars Sales (Volume) and Market Share Comparison by Applications

(2020-2027 ) table defined for each application/end-users

Oncology Biosimilars Sales and Growth Rate (2020-2027)

Oncology Biosimilars Competition by Players/Suppliers, Region, Type and Application

Oncology Biosimilars (Volume, Value and Sales Price) table defined for each geographic region defined.

Oncology Biosimilars Players/Suppliers Profiles and Sales Data

Additionally Company Basic Information, Manufacturing Base and Competitors list is being provided for each listed manufacturers

Market Sales, Revenue, Price and Gross Margin table for each product type which include , Product Type I, Product Type II & Product Type III

Oncology Biosimilars Manufacturing Cost Analysis

Oncology Biosimilars Key Raw Materials Analysis

Oncology Biosimilars Chain, Sourcing Strategy and Downstream Buyers, Industrial Chain Analysis

Market Forecast (2020-2027)

……..and more in complete table of Contents

Key questions answered in this report

What will the market size be in     2027 and what will the growth rate be

What are the key market trends?

What is driving Oncology     Biosimilars Market?

What are the challenges to     market growth?

Who are the key vendors in     Market space?

What are the key market trends     impacting the growth of the Oncology Biosimilars Market ?

What are the key outcomes of     the five forces analysis of the Oncology Biosimilars Market?

What are the market opportunities and threats faced by the vendors in the Oncology Biosimilars market? Get in-depth details about factors influencing the market shares of the Americas, APAC, and EMEA?

About Data Bridge Market Research:

An absolute way to forecast what future holds is to comprehend the trend today! Data Bridge set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market.

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