FDA-Approved Biosimilars Market: A Complete List & Latest Developments 2025-2033 | Most Leading Companies - Amgen Inc., Pfizer Inc., Sandoz Group AG, Teva Pharmaceuticals USA, Inc., Biogen, Biocon Biologics Inc

Global Biosimilars market size reached US$ 22.58 billion in 2024 and is expected to reach US$ 171.79 billion by 2033, growing at a CAGR of 25.5% during the forecast period 2025-2033.

Biosimilars Market report, published by DataM Intelligence, provides in-depth insights and analysis on key market trends, growth opportunities, and emerging challenges. Committed to delivering actionable intelligence, DataM Intelligence empowers businesses to make informed decisions and stay ahead of the competition. Through a combination of qualitative and quantitative research methods, it offers comprehensive reports that help clients navigate complex market landscapes, drive strategic growth, and seize new opportunities in an ever-evolving global market.

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Biosimilars are biologic medical products highly similar to an already approved reference biologic, with no clinically meaningful differences in terms of safety, purity, and potency. They offer cost-effective alternatives to biologic therapies, improving patient access to advanced treatments.

List of the Key Players in the Biosimilars Market:

Amgen Inc., Pfizer Inc., Sandoz Group AG, Teva Pharmaceuticals USA, Inc., Biogen, Biocon Biologics Inc., Boehringer Ingelheim International GmbH, Samsung Bioepis, Dr. Reddy's Laboratories Ltd., Fresenius Kabi AG

Industry Development:

In March 2025, Celltrion announced that the U.S. Food and Drug Administration (FDA) had approved OMLYCLO (omalizumab-igec) as the first and only interchangeable biosimilar to XOLAIR (omalizumab). OMLYCLO is approved for treating moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergies, and chronic spontaneous urticaria (CSU).

Growth Forecast Projected:

The Global Biosimilars Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2033. In 2023, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Biosimilars Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Segment Covered in the Biosimilars Market:

By Product Type: Monoclonal Antibodies, Recombinant Human Growth Hormone (rhGH), Insulin, Anti-coagulants, Erythropoietin, Granulocyte Colony Stimulating Factor, Follitropin, Interferons, Others

By Application: Oncology, Chronic Diseases, Autoimmune Diseases, Infectious Diseases, Growth Hormone Deficiency, Hematology, Others

Regional Analysis for Biosimilars Market:

The regional analysis of the Biosimilars Market covers key regions including North America, Europe, Asia Pacific Middle East and Africa and South America. The North America with a focus on the U.S., Canada, and Mexico; Europe, highlighting major countries like the U.K., Germany, France, and Italy, along with other nations in the region; Asia-Pacific, covering India, China, Japan, South Korea, and Australia, among others; South America, with emphasis on Colombia, Brazil, and Argentina; and the Middle East & Africa, which includes Saudi Arabia, the U.A.E., South Africa, and other countries. This comprehensive regional breakdown helps identify unique market trends and growth opportunities specific to each area.

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

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

Benefits of the Report:

➡ A descriptive analysis of demand-supply gap, market size estimation, SWOT analysis, PESTEL Analysis and forecast in the global market.

➡ Top-down and bottom-up approach for regional analysis

➡ Porter's five forces model gives an in-depth analysis of buyers and suppliers, threats of new entrants & substitutes and competition amongst the key market players.

➡ By understanding the value chain analysis, the stakeholders can get a clear and detailed picture of this Market

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People Also Ask:

➠ What is the global sales, production, consumption, import, and export value of the Biosimilars market?

➠ Who are the leading manufacturers in the global Biosimilars industry? What is their operational status in terms of capacity, production, sales, pricing, costs, gross margin, and revenue?

➠ What opportunities and challenges do vendors in the global Biosimilars industry face?

➠ Which applications, end-users, or product types are expected to see growth? What is the market share for each type and application?

➠ What are the key factors and limitations affecting the growth of the Biosimilars market?

➠ What are the various sales, marketing, and distribution channels in the global industry?

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