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newsmarketreports · 28 days ago

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Celltrion Inc.: Financial Performance Overview

Celltrion Financials is a South Korean biopharmaceutical company, known for its leadership in developing biosimilars and biologics. The company focuses on producing affordable, high-quality biologic drugs for the treatment of autoimmune diseases, cancer, and other chronic illnesses. Below is a summary of its financial performance based on available information.

1. Revenue Growth

Strong Sales of Biosimilars: Celltrion has seen consistent growth in revenue, primarily driven by the global sales of its biosimilars such as Remsima (a biosimilar to Remicade), Truxima (a biosimilar to Rituxan), and Herzuma (a biosimilar to Herceptin). These products are approved in multiple regions, including the U.S., Europe, and Asia, contributing significantly to the company's topline.

Year-over-Year Revenue Increase: Celltrion has experienced strong revenue growth in recent years, often reporting double-digit percentage increases in annual sales. This growth is fueled by increasing market adoption of biosimilars and new product launches.

2. Profit Margins

High Gross Margins: Celltrion benefits from relatively high gross margins due to the cost-efficiency of its manufacturing processes and the lower R&D costs associated with biosimilars compared to original biologic drugs. Its state-of-the-art manufacturing facilities in South Korea contribute to economies of scale.

Operating Income: The company’s operating income has also been growing steadily, supported by both rising sales and cost-control measures. Celltrion’s ability to scale production efficiently while maintaining competitive pricing has been a key driver of profitability.

3. R&D Expenditure

Investments in Pipeline Development: Celltrion continues to invest heavily in research and development (R&D), focusing on expanding its biosimilar pipeline and developing new biologic treatments. This includes the development of biosimilars for blockbuster drugs as well as innovative biologics for cancer and autoimmune diseases.

R&D as a Percentage of Revenue: Celltrion’s R&D expenditure represents a significant portion of its annual revenue, reflecting its long-term commitment to innovation and expanding its product portfolio. The company is focused on developing next-generation biologics and biosimilars, which will drive future growth.

4. Global Market Expansion

International Sales Contribution: A significant portion of Celltrion’s revenue comes from its international operations, particularly in Europe and the U.S., where biosimilars have gained widespread acceptance. The company has been actively pursuing regulatory approvals in various regions, which has contributed to its robust revenue growth.

Partnerships and Alliances: Celltrion has established strategic partnerships with global pharmaceutical companies for the marketing and distribution of its biosimilar products. These partnerships have played a key role in driving global sales and market penetration.

5. Impact of COVID-19

COVID-19 Treatment Development: During the COVID-19 pandemic, Celltrion played an active role in developing treatments for the virus. The company developed Regkirona (CT-P59), a monoclonal antibody treatment for COVID-19. This has contributed to additional revenue streams and positioned the company as a key player in pandemic response efforts.

Increased Demand for Biologics: The pandemic heightened the global demand for biologics, which benefited Celltrion’s biosimilar portfolio as healthcare systems sought cost-effective treatments for chronic diseases amidst budget constraints.

6. Outlook and Future Growth

Biosimilar Pipeline: Celltrion’s future growth is expected to be driven by the launch of new biosimilars currently in its pipeline. These include biosimilars for drugs like Humira (adalimumab), which has been one of the world’s top-selling drugs, and other monoclonal antibodies.

Innovative Biologics: Beyond biosimilars, Celltrion is working on developing innovative biologic treatments that could further bolster its revenue streams and market position.

Expansion into New Markets: Celltrion continues to focus on expanding into new international markets, particularly in emerging regions where demand for affordable biologic treatments is increasing.

Conclusion

Celltrion Inc. has demonstrated strong financial performance, supported by its leadership in the biosimilar market, efficient manufacturing capabilities, and strategic international partnerships. With a robust product pipeline, continued R&D investments, and a focus on global market expansion, Celltrion is well-positioned for future growth in the biopharmaceutical industry.

#Celltrion Financials

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devikamore · 4 months ago

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atomicgalaxywinner · 5 months ago

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diptinaik · 9 months ago

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techninja · 1 year ago

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Remicade Biosimilars in 2023: Advancements and Market Impact

Introduction:

In recent years, the development and approval of biosimilars have revolutionized the pharmaceutical industry, providing more affordable treatment options for patients with complex diseases. One such significant breakthrough is Remicade biosimilars. In 2023, these biosimilars continue to gain traction, offering promising therapeutic alternatives and transforming the landscape of autoimmune disease treatment.

Understanding Remicade and Biosimilars:

Remicade (generic name: infliximab) is a monoclonal antibody biologic drug that has been widely used to treat various inflammatory conditions such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis, and ankylosing spondylitis. It works by targeting and inhibiting tumor necrosis factor alpha (TNF-α), a pro-inflammatory cytokine.

Biosimilars, on the other hand, are highly similar versions of the reference biologic drug (in this case, Remicade) that have undergone rigorous comparability testing to demonstrate similarity in terms of efficacy, safety, and quality. They offer the potential for increased competition, lower treatment costs, and improved accessibility to patients.

Advancements in Remicade Biosimilars:

1. Regulatory Approvals: In 2023, several countries have granted regulatory approvals for Remicade biosimilars, allowing for their commercialization and use. These approvals signify the confidence of regulatory agencies in the safety, efficacy, and quality of these biosimilars.

2. Expanded Therapeutic Indications: Biosimilars of Remicade have expanded their therapeutic indications to cover a wide range of inflammatory diseases. This expansion has opened new treatment possibilities for patients who previously had limited options due to high costs or lack of availability.

3. Improved Manufacturing Processes: Over the years, advancements in manufacturing processes have led to increased efficiency and reduced costs in producing Remicade biosimilars. These improvements have contributed to the affordability and wider accessibility of these treatments.

Market Impact:

The introduction and adoption of Remicade biosimilars have had a significant impact on the healthcare industry and patient outcomes.

1. Increased Competition and Cost Savings: The entry of biosimilars into the market has created healthy competition, driving down the prices of Remicade and its biosimilars. This competition has resulted in cost savings for patients and healthcare systems, making treatment more affordable and sustainable.

2. Enhanced Access to Treatment: The availability of biosimilars has improved access to Remicade therapy for patients in regions where the original product was previously unaffordable or inaccessible. This increased access ensures that more patients can benefit from these life-changing treatments.

3. Shifting Treatment Paradigm: The introduction of Remicade biosimilars has prompted healthcare providers to reassess their treatment strategies, considering the comparable efficacy and safety profiles of biosimilars. This shift has encouraged the adoption of biosimilars as a viable alternative to the reference product, providing more treatment options to patients.

Conclusion:

The emergence of Remicade biosimilars in 2023 represents a significant step forward in healthcare, offering patients more affordable and accessible treatment options for autoimmune diseases. Regulatory approvals, expanded therapeutic indications, improved manufacturing processes, increased competition, and cost savings have collectively contributed to the growing acceptance and adoption of these biosimilars. As we move forward, Remicade biosimilars are expected to play an increasingly important role in revolutionizing autoimmune disease treatment and improving patient outcomes.

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delicatemagazinedreamer · 2 years ago

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Essential Things You Need to Know Remicade Biosimilars

A biosimilar is a category of biological product that is very similar to a medicine that has already received FDA approval, also referred to as a reference biological product. The U.S. FDA and the European Medicines Agency (EMA) both licence Remicade Biosimilars Market, which are identical to reference pharmaceuticals in terms of safety, purity, efficacy, and effectiveness.

Read more @ https://digitalgrowinfo.blogspot.com/2022/08/things-you-may-not-know-about-remicade.html

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soumyafwr · 4 months ago

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https://zekond.com/read-blog/59032_remicade-biosimilar-market-share-overview-competitive-analysis-and-forecast-2031.html

Remicade Biosimilar Market Share, Overview, Competitive Analysis and Forecast 2031

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martynnx-blog · 6 years ago

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

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

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myabhijitr · 6 years ago

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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

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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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pranalipawarshinde · 2 years ago

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Biosimilars Market to advance at a CAGR of 15.5% from 2022 to 2031

Biosimilars Market Outlook 2031

The global biosimilars market was valued at US$ 20.4 Bn in 2021

The global market is expected to advance at a CAGR of 15.5% from 2022 to 2031

The global biosimilars market is anticipated to reach more than US$ 85 Bn by the end of 2031

Report Ovreview: https://www.transparencymarketresearch.com/biosimilars-market.html

Overview of Biosimilars Market

Biosimilar can be defined as a biologic medical product, which is considered very similar to an already-approved biologic. These biosimilars are approved based on their efficacy, quality, safety, and the standards of pharmaceutical quality that apply to all biologic medicines.

Biosimilars are generic versions of biologics that have passed their patent expiration date. The global biosimilars market is expected to be driven by patent expiration of well-known biologics. Increase in approval and sales of biosimilars has led to a significant decline in sales of biologics that had a steady or growing demand.

The burden of chronic diseases has been rising across the globe. Increase in prevalence of chronic diseases can be largely ascribed to the aging population and changing lifestyle of the people. Diabetes, hypertension, stroke, respiratory diseases, oral diseases, obesity, arthritis, and cancer are some of the common chronic diseases. On the other hand, biosimilar monoclonal antibodies are being extensively used in the treatment of rheumatoid arthritis and cancer.

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Approvals of biosimilars have been increasing globally owing to changing regulations and rise in pressure on healthcare systems to facilitate treatment for all patients. Biosimilars or copy biologics are being increasingly adopted by physicians, authorities, and patients, owing to the much-needed improvements in the access to therapeutically viable options for the treatment of various diseases. Companies are increasing the production of biosimilar medicines, oncology biosimilars, and Remicade biosimilars to broaden their revenue streams.

High Prevalence of Chronic Diseases and Rise in Number of Cancer Patients to Boost Biosimilars Market

Rise in prevalence of chronic diseases is augmenting the global market. Biosimilar drugs are becoming increasingly popular across the world because of their cost-effectiveness. Increase in cancer patients and chronic disease cases; and growth in geriatric population are projected to fuel the demand for biosimilars during the forecast period.

Over half of the population of the U.S. is likely to suffer from at least one chronic disease during their lifetime. According to the WHO, chronic disease prevalence is expected to rise by 57% by 2020. Rapid population growth in emerging markets is expected to drive the prevalence of chronic diseases.

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Cancer is the second leading cause of death globally, with over 70% of deaths occurring in low- and middle-income countries. The incidence of cancer increases with age, most likely due to the rise in risk of specific cancers as people get older. Growth in pipeline of biosimilar drugs for the treatment of chronic diseases is projected to propel the global biosimilars market in the next few years. ABRILADA, a biosimilar to Humira, was approved by the U.S. Food and Drug Administration (FDA) in November 2019 for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis.

Changing Government Regulations to Augment Demand for Recombinant Non-glycosylated Protein Products

In terms of product, the recombinant non-glycosylated proteins segment held a relatively large market share in 2021. The segment has been split into insulin, granulocyte colony stimulating factor, recombinant human growth factor, and interferons.

Recombinant non-glycosylation involves the production of active substances in bacteria, which results in non-glycosylation, allowing the active substance to remain biologically active. Growth of the segment can be attributed to the rise in the prevalence of chronic diseases, which require recombinant non-glycosylated proteins biosimilars for treatment. Additionally, changing regulations and increase in focus of governments on the approval of biosimilars are anticipated to drive the recombinant non-glycosylated proteins segment during the forecast period.

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Advancements in Biomedical Technology to Drive Oncology Treatments

Based on indication, the oncology segment held large revenue share of the global biosimilars market in 2021. Growth in prevalence of cancer and increase in the number of ongoing studies in the biosimilars filed across the world are likely to augment the segment during the forecast period.

Biologics are a broad category of products that include blood and blood components, vaccines, hormones, and allergens (anti-allergy medications). Monoclonal antibodies are important biologics; these are used to treat a range of diseases, including breast cancer, lymphoma, rheumatoid arthritis, psoriasis, ulcerative colitis, and Crohn's disease.

Advancements in biomedical technology have resulted in an increase in commercialization of biologics in the last few decades. This has improved cancer care. Cancer treatment is expensive; therefore, development of a biosimilar product with comparable clinical efficacy has led to lower healthcare costs and improved access to care. Hence, the oncology segment is expected to account for significant share of the market during the forecast period.

Regional Outlook of Global Biosimilars Market

Europe held more than 45% share of the global biosimilars market in 2021. It is projected to be a highly lucrative region of the global market, with high market attractiveness index, during the forecast period.

The biosimilars market in Europe is the largest in the world, accounting for roughly 60% of the global biosimilars market and growing steadily year after year. As of October 2019, 54 biosimilars of 15 originator biological medicines were approved for marketing in Europe. Countries in Europe provide valuable examples of different approaches to biosimilars policy, led by their large biosimilars markets and diverse healthcare systems.

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Biosimilars sales reflect Europe's legislative and regulatory leadership in the market. The biosimilars markets in the region is more mature than that in the U.S. However, opportunities for biosimilars companies in Europe are limited due to lower overall spending on biologicals.

Europe has set the standard, approving more treatments than any other continent. Currently, biosimilars account for 10% of the total biologics market in the region, with a majority (7%) occurring in the past five years. The percentage is significantly higher in terms of volume, reflecting the steadily increasing level of revenue savings as a result of the rise in biosimilars competition and penetration. More than 60 biosimilars have been approved for use in the European Union (EU) to date, with several more being evaluated. Therefore, the biosimilars market in Europe is expected to grow at a significant pace during the forecast period.

Analysis of Key Players in Biosimilars Market

The global biosimilars market is consolidated, with a small number of leading players accounting for a relatively large share. Most of the companies are making significant investments in research & development activities. Diversification of product portfolio and mergers & acquisitions are important strategies adopted by key players in the global biosimilars market. Pfizer, Inc., Intas Pharmaceuticals Ltd., Biocon, Dr. Reddy’s Laboratories Ltd., Teva Pharmaceutical Industries Ltd., Sandoz International GmbH (A Novartis Division), Celltrion, Inc., Amgen, Inc., STADA Arzneimittel AG, and Apotex, Inc. are the prominent players operating in the global biosimilars market.

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deannaanderson · 2 years ago

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Importance of BioSimilar Attorneys

The Biologics Price Competition and Innovation Act (BPCIA), formed in 2010 as part of the Affordable Care Act, lead a new era for large-molecule therapeutics. It provided an short pathway for regulatory approval of biosimilar and interchangeable biologics, also it introduced a statutory framework for resolving patent disputes involving those products.

In order to understand the complexity of biosimilar market domain a well informed and experienced Bio similar attorney which offer best practices & offers clients both the subject matter expertise and the trial savvy hands-on experience to effectively operate, and prevail, in this new era.

A bio similar attorney in many ways is identical to Hatch Waxman which operates within the exacting statutory framework of the BPCIA. Working within that model requires a team with precise knowledge of process, a deep domain knowledge in science, and extensive litigation experience.

Now coming to the question will taking Biosimilars Save Me Money?

The short answer: maybe, but not yet. Here’s why:

Biologics is an expensive process to manufacture. They’re expensive for customers to buy. Even a single dose can range from $10,000 and up or way up that $10,000. Though your insurance policy likely covers most of that cost, but there’s still a big collision on our overall health care costs because these very effective drugs are very expensive.

Before the approval, health insurers will get this update loud and clear and have started paying patients to try the biosimilar variants of medications to make this more spreaded use in an effort to manage the costs. According to the Biologics Price Competition and Innovation Act enacted back in 2009 was a U.S. legislation introduced by Congress to set up a “fast-track” development and approval proceedings for biosimilars.

It was part of a larger set of legislation called the Patient Protection and Affordable Care Act (ACA) passed in 2010. Once the BPCIA became law, the FDA set up a multi-step process for drug manufacturers to follow and develop a biosimilar.

Because of the many analytical and human tests done in the past have shown that few biosimilars are highly identical to its reference product that are safe and equivalently effective for consumption. In the FDA’s policy there wasn’t any need for a new biosimilar to duplicate clinical trials in patients with every disease. By doing so, the development of a biosimilar could save time and money.

Biosimilars cost less than their reference drugs. However, patients in the U.S. have not seen direct cost savings yet.

Certain manufacturers of biosimilars have started to market these drugs at much lower costs than their reference products. For example, infliximab-dyyb (Inflectra®) was introduced at a price that was 19 percent lower than infliximab’s (Remicade®) list price. Then in 2020, infliximab-axxq (Avsola®) was introduced at a list price that was 57 percent lower than infliximab’s (Remicade®) list price. However, those lower list prices have not resulted in lower costs for customers because insurance companies and pharmacy benefit managers do not pass these savings.

Health insurance companies say the lower price biosimilars, which are not passed on to patients, help to keep the price of premiums in check.

According to a nonprofit that analyzes many programs and industries, published a report in 2017 that analyzed that, overall, biosimilars by 2026 would cut spending on biologics by $54 billion. The drawback of this system is that it is set up in such a way that none of these savings go directly to the producers. When the cost is low for manufacturing, testing & marketing biosimilars could result in savings for the healthcare system, which in turn will yield good results for the medical healthcare domain.

Being a patient, it is your right to get some relief from rising drug costs. According to the group of America’s Health Insurance Plans (AHIP), as more biosimilars are being approved and allows to enter the market, competition will increase and prices will surely come down.

The FDA is observing the momentum of how the cost savings for biosimilars (or other drugs) are regulated from their manufacturer into the market, and in the end by the consumer. There may be savings on some front from the corporate rebates or discounts that are not passed on to you at this time. Hopefully, it is soon going to change so that you will pay less.

The attorney will make sure that the patient, deserve relief from rising drug costs. As per the solicit group of America’s Health Insurance Plans (AHIP), as more and more biosimilars are approved and are launched in the market, a health competition will increase and prices will eventually come down.

Strengths of Experienced Bio Similar Attorney

Up-to-date knowledge of biosimilars legislation

IP litigators with numerous trial and appellate successes

Extensive Hatch Waxman litigation experience

Successful Post-Grant PTO practice on behalf of patent owners and petitioners

Extensive experience in biologics patent prosecution

Licensing and other transactional experience related to biologics

Looking for- Biosimilars Litigation Attorneys

The bottom line is that it is the duty of your attorney to make sure that every drug produced which has been approved for your customers by the FDA meets the required standards within the FDA’s framework. This includes both biosimilars and biologics. Being a prescription drug, in the U.S., the FDA would keep an eye as they are manufactured.

In few years there will likely be more biosimilars coming onto the market. Some of which that are already approved, but caught up in lawsuits, should become easily available to patients at a lower market cost.

So if you’re using a biologic now, and consideration that producing a new biosimilar drug and you are curious about whether a biosimilar may be a lucrative option for you, here are some tips:

Speak to your attorney. Find out if there is a biosimilar that is available, and if your attorney thinks it may be right for you then you should consider producing the same

Find out if your insurance plan covers the biosimilar. If it doesn’t, then let your attorney notify you whenever your biosimilar is available.

Ask your doctor and your pharmacist to explain how the biosimilar will work as part of your treatment plan. As your duty, it is completely fine for you to ask any question that you have about its safety, effectiveness, and cost.

Therefore, to stay on top of things it is important to take care of all your legal affair sure way to free yourself from unnecessary headaches. It is always a good idea to have a Biosimilar attorney close to you even if you do not have problems at the moment.

#biosimilar drugs

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healthcare-market · 3 years ago

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Remicade Biosimilar Market Shares, Strategies and Opportunities 2031

Remicade Biosimilar Market: Overview

A key drive for Remicade biosimilar market stems from the fact that numerous biological innovative products, including monoclonal antibodies (mAbs) are nearing patent expiries. A growing research on developing biosimilars to these is a key trend bolstering the growth prospects. A number of biosimilars to Infliximab (IFX) biological therapy have been approved, notably by the FDA. In the past, IFX was found to be effective in Crohn’s disease (CD) and ulcerative colitis (UC). Particularly, biological therapies including Remicade biosimilar exhibit vast revenue potential for inflammatory bowel disease (IBD). A relentless focus on reducing the overall cost of chronic diseases notably IBD-related healthcare is a key aspect propelling advances in this direction. Great strides have been made in efficacy and safety data, which underpin potential revenue streams in the Remicade biosimilar market. Newer FDA-approved products in the market target patients with ankylosing spondylitis, plaque psoriasis, and psoriatic arthritis.

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Constant focus on expansion of biosimilar portfolios by globally prominent drug makers is a key trend bolstering the prospects in the Remicade biosimilar market. They are increasingly inclined toward offering affordable biological treatment options especially in oncology. However, developing Remicade biosimilar that have low risk factors particularly from risk for serious infection of opportunistic pathogens is veritable challenge that will anchor more research and development funding worldwide.

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Demand for biological products is high for the treatment of a large number of diseases. However, demand for biosimilar products is increasing to lower health care costs. Biosimilar products are derived in reference to biological products and have similar safety, efficacy, purity, and effectiveness when compared to the original products. Biosimilar can be characterized as a sort of biologic item that is profoundly like an as of now FDA approved biologic drug, known as reference drug. Biosimilars are drugs approved by the U.S. FDA and the European Medicine Agency (EMA) and show no clinical and meaningful difference from the reference biological product. These biosimilar products can be approved only for indications which are previously approved for the reference biological product by authorized regulatory bodies.

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In 1998, the U.S. FDA licensed Remicade (infliximab), a monoclonal antibody originally produced by Janssen Biotech, Inc. and Merck & Co. in partnership. Its primary indication included Crohn’s disease in both adult and pediatric patients. It is also indicated for the treatment of ulcerative colitis, spinal psoriatic arthritis, plague psoriasis, and rheumatic arthritis when given in combination with methotrexate. The U.S. FDA approved biosimilar to Remicade named Inflectra on April 05, 2016. Pfizer launched Inflectra in the market at 15% discount on the original market price of the reference product. However, in April 2017, another biosimilar Renflexis (infliximab-abda), a tumor necrosis factor to Remicade by Samsung Bioepis and Merck & Co., was approved to be launched into the market. It is approved for almost all the indications that were approved under Remicade such as ulcerative colitis, spinal psoriatic arthritis, plague psoriasis, rheumatic arthritis, and ankylosing spondylitis.

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Increase in incidence of autoimmune disorders such as rheumatoid arthritis, and psoriasis, patent expiry of branded drugs, and rise in health care costs drive the Remicade biosimilar market. Additionally, faster entry of Biosimilars into the Europe market leads to cost reduction and faster medicines accessibility help to grow this market. However, serious side effects associated with the drug could lead to fatality. This factor restraints the market.

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The global Remicade biosimilar market can be segmented based on approved indication and region. In terms of approved indication, the market can be categorized into ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis. Ulcerative colitis and rheumatoid arthritis show higher demand due to increase in number of cases of these diseases. Psoriasis also increase market demand owing to increase in the cases of autoimmune diseases. Based on region, the global Remicade biosimilar market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominates the market owing to high incidence of autoimmune diseases and increase in geriatric population. Europe is the second largest market for Remicade. Easy access to biosimilar medications in the region drives the market. India, southeast Asia, and China are emerging markets for biosimilar medicines because of changing lifestyle and increase in healthcare facilities in these regions.

Key players in the global Remicade biosimilar market comprise Alvogen, Napp Pharmaceuticals, Janssen Biotech, Inc., Merck &Co., Pfizer, Inc., Cell Trion, and Nippon Kayaku.

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gordonwilliamsweb · 3 years ago

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Biosimilar Drugs Are Cheaper Than Biologics. Are They Similar Enough to Switch?

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than four years trying medications before getting her disease under control with a biologic drug called Remicade.

So Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Moxley, who recently started a job as a public relations coordinator for Kansas City Public Schools in Missouri. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the U.S. has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

��It distorts the market and makes it so that patients can’t get access,” said Dr. Jinoos Yazdany, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anti-competitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the U.S. but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the healthcare system at-large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much — 14.6% — according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the U.S.

Biosimilars provide a roughly 30% discount over brand biologics in the U.S. but have the potential to reduce spending by more than $100 billion in the next five years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Dr. Marcus Snow, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Dr. Ross Maltz, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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stephenmccull · 3 years ago

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Biosimilar Drugs Are Cheaper Than Biologics. Are They Similar Enough to Switch?

“It distorts the market and makes it so that patients can’t get access,” said Dr. Jinoos Yazdany, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

Biosimilars provide a roughly 30% discount over brand biologics in the U.S. but have the potential to reduce spending by more than $100 billion in the next five years, the IQVIA analysis found.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Situations like Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

In her new job, Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

USE OUR CONTENT

This story can be republished for free (details).

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adityarana1687-blog · 3 years ago

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Ankylosing Spondylitis Market Projected To Have Valuation Worth USD 7.9 Billion By 2025

The global ankylosing spondylitis market size is expected to reach USD 7.9 billion by 2027 registering a CAGR of 8.3%, according to a new report by Grand View Research, Inc. Presence of a strong product pipeline is likely to accelerate market growth. For instance, the positive phase-2b results of UCB S.A. pipeline product, Bimekizumab, makes it a potential drug candidate to be launched in the market over the forecast period.

Pharmaceutical companies are aiming at label expansion and patent extension for maintaining their share in the market. In October 2017, Johnson & Johnson Services received approval for Simponi Aria for AS treatment for the treatment active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). Such advancements in therapy area are expected to have a positive effect on the market growth.

Furthermore, presence of favorable reimbursement policies is anticipated to propel the growth. For instance, in Canada (Ontario) under the province’s public drug program, Novartis AG announced the reimbursement of Cosentyx for the treatment of ankylosing ankylosis. According to an article published by Novartis AG, approximately 20 to 40% of patients fail to achieve sufficient clinical improvement on anti-TNF drugs, which provides opportunities for companies to develop novel and effective drugs.

Request a free sample copy or view report summary: Ankylosing Spondylitis Market Report

Ankylosing Spondylitis Market Report Highlights

Humira was the largest revenue-generating drug in 2019 and accounted for over 25% of the market share due to the favorable pricing and lack of biosimilar competition in North America

Cosentyx is estimated to be the fastest-growing segment due to its excellent clinical profile. In addition, the product is patent protected for ankylosing spondylitis till 2033 in U.S. till and 2030 in Europe

North America led the market in 2019 due to the presence of key biopharmaceutical & pharmaceutical companies and increased funding and research initiatives

Key companies are adopting strategies, such as product development, M&A, and regional expansion, to increase their market share

For instance, in January 2019, Samsung Bioepis Co., Ltd. announced the strategic partnership with 3SBio Inc. to expand its product portfolio in China

Ankylosing Spondylitis Market Segmentation

Grand View Research has segmented the global ankylosing spondylitis market based on drug and region:

Ankylosing Spondylitis Drug Outlook (Revenue, USD Million, 2016 - 2027)

Cosentyx

Humira

Simponi

Remicade

Enbrel

Cimzia

Others

Ankylosing Spondylitis Regional Outlook (Revenue, USD Million, 2016 - 2027)

North America

Europe

Asia Pacific

Latin America

Middle East & Africa

U.S.

Canada

U.K.

Germany

France

Italy

Spain

Japan

China

India

Australia

South Korea

Brazil

Mexico

Chile

Columbia

Argentina

South Africa

Saudi Arabia

UAE

List of Key Players of Ankylosing Spondylitis Market

AbbVie, Inc.

Amgen, Inc.

Pfizer, Inc.

Novartis AG

Eli Lilly and Company

UCB, Inc.

Johnson & Johnson Services, Inc.

Merck & Co., Inc.

About Grand View Research

Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.

#Ankylosing Spondylitis Market

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