United States Biosimilars Market is expected to reach US$ 171.79 billion by 2033 | Top key players - Amgen Inc., Pfizer Inc., Biogen.

Market Size and Growth:

The 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. The Market is driven by rising demand for cost-effective biologic therapies, increasing patent expirations of branded drugs, and expanding regulatory approvals worldwide. According to DataM Intelligence

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The Biosimilars Market refers to the industry focused on developing and commercializing biologic medical products that are highly similar to already approved reference biologics in terms of safety, efficacy, and quality. These cost-effective alternatives help reduce healthcare expenses, expand patient access to advanced therapies, and drive competition across therapeutic areas such as oncology, autoimmune diseases, and diabetes.

Industry Recent Developments:

Industry Recent Developments: United States

✅ July 2025: The U.S. biosimilar market is poised for growth with fast-track FDA approvals, particularly in immunology, oncology, and endocrinology, with key upcoming biosimilars for drugs like Cosentyx, Entyvio, Keytruda, and Trulicity expected to drive adoption and lower prices.

✅ August 2025: The FDA increased the incentive add-on payment for biosimilars under Medicare Part B from 6% to 8%, fostering higher use of lower-cost biosimilars relative to originator biologics.

✅ September 2025: Biosimilar sales generated approximately $20.2 billion in savings for the U.S. healthcare system in 2024, with 72 FDA-approved biosimilars available. Continued approval of new biosimilars was noted, including for drugs such as Stelara and Actemra.

Industry Recent Developments: Japan

✅ July 2025: Market growth driven by aging population, government support, and oncology biosimilars uptake. Strategic partnerships, such as Biocon's collaboration with Sandoz to market Adalimumab biosimilar, strengthened biosimilar availability.

✅ September 2025: Alvotech's commercialization partner Fuji Pharma received marketing approval from Japan's Ministry of Health for three biosimilars-AVT03 (denosumab), AVT05 (golimumab), and AVT06 (aflibercept). AVT05 is the first golimumab biosimilar approved in a major market globally.

✅ September 2025: Anticipated launches by Celltrion of biosimilars including denosumab, aflibercept, ustekinumab, omalizumab, and tocilizumab targeted for the Japanese market within 2025.

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FDA Approvals / Major FDA actions (2025):

✅ Multiple biosimilars listed as FDA-approved in 2025 - notable entries include denosumab biosimilars (e.g., Bomyntra / Conexxence and Stoboclo / Osenvelt), an omalizumab biosimilar (Omlyclo), and an insulin aspart biosimilar (Merilog). These are shown on the FDA's biosimilar product information page with 2025 dates.

✅ FDA accepted a Biologics License Application (BLA) for AVT06 (aflibercept biosimilar) - Alvotech + Teva's BLA for AVT06 (proposed biosimilar to EYLEA®) was accepted for review in Feb 2025 with companies targeting regulatory completion later in 2025.

Regulatory Developments (EMA / policy):

✅ EMA initiatives / positive opinions in 2025 - the EMA announced work to streamline biosimilar development and in mid-2025 CHMP/EMA issued positive opinions for several biosimilars (including aflibercept candidates and others), reflecting active activity in ophthalmology and immunology biosimilars.

✅ Region-specific approvals and industry filings - several companies reported regulatory milestones (e.g., EU positive opinions or BLA filings in the US) for ustekinumab, aflibercept and other molecules during 2025 as the market shifts into higher-value biologics categories.

Mergers, Acquisitions & commercial deals (2025):

✅ Intas / UDENYCA (pegfilgrastim) deal - Intas completed acquisition/assumption of the UDENYCA (pegfilgrastim) business (previously Coherus' asset) as part of Coherus' divestment; the deal and transitions were publicly reported in 2024-2025 and completed operations/transfers in 2025. This is a clear example of a company buying an FDA-approved biosimilar franchise to scale commercial presence.

✅ Partnerships and license activity (example: Alvotech-Teva) - beyond outright M&A, major commercial partnerships and licensing (e.g., Teva's U.S. collaboration with Alvotech for AVT06) were a key route used in 2025 to enter the U.S. biosimilar market. These strategic collaborations often accompany BLA filings and expected launches.

Major Key Players:

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

Segments 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:

⇥ 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)

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Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Biosimilars market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Biosimilars Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Biosimilars market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Biosimilars Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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Frequently asked questions:

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

➠ Who are the global key manufacturers of the Biosimilars Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the Biosimilars market opportunities and threats faced by the vendors in the global Biosimilars Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the Biosimilars market?

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

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