Biosimilars and Biologics Market is expected to reach US$ 1,773.77 Billion by 2033 | Top Companies - Amgen Inc., Johnson & Johnson, Biogen Inc., Pfizer Inc.

Market Size and Growth:

The Biosimilars and Biologics Market Size reached US$ 531.45 Billion in 2024 and is expected to reach US$ 1,773.77 Billion by 2033, growing at a CAGR of 14.4% during the forecast period 2025-2033. According to DataM Intelligence Report.

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The Biosimilars and Biologics Market encompasses therapeutic products derived from living organisms, including monoclonal antibodies, vaccines, and recombinant proteins. Biologics are innovative, high-complexity drugs, while biosimilars are highly similar, cost-effective versions of approved biologics. This market focuses on advanced disease management, improved treatment accessibility, and expanding commercialization driven by patent expiries, R&D progress, and increasing demand for targeted therapies.

United States: Recent Developments of Biosimilars and Biologics Market

✅ October 2025: The FDA released new draft guidance aimed at accelerating biosimilar approvals and reducing healthcare costs, which could unlock an estimated $181 billion in savings over the next five years. This framework intends to replace bureaucratic hurdles with scientific approaches and promote competition.​

✅ November 2025: The FDA approved multiple biosimilars for denosumab and pertuzumab, enhancing market competition, particularly in oncology and bone health, reflecting a trend toward regulatory modernization and increased market access.​

✅ December 2025: Ongoing strategic regulatory changes are expected to further speed biosimilar development timelines, attract new market entrants, and increase availability of lower-cost biologics, thereby expanding treatment options.​

Europe: Recent Developments of Biosimilars and Biologics Market

✅ October 2025: Europe maintained its lead in biosimilar uptake, buoyed by the EMA's supportive regulatory stance. The market is adapting to biosimilars being interchangeable, with a diverse range of biosimilars competing against originator drugs like Humira.​

✅ November 2025: Fresenius Kabi launched its biosimilars for denosumab in Europe, supported by comprehensive patient and healthcare provider programs, contributing to broader access and healthcare system sustainability.​

✅ December 2025: Biocon Biologics finalized an agreement with Amgen to commercialize denosumab biosimilars Vevzuo and Evfraxy in Europe starting December 2, expanding biosimilar availability in the region.​

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Key FDA / Regulatory Approvals in (2025):

✅ Denosumab biosimilars - Osvyrti and Jubereq - FDA approved denosumab biosimilars in October 2025 (biosimilar to Prolia/Xgeva). This is notable because denosumab is an important bone-loss/oncology agent and these approvals expand biosimilar competition in that class.

✅ Aflibercept biosimilar - Eydenzelt - FDA listed an aflibercept biosimilar approval in October 2025 (biosimilar to Eylea), opening competition in the high-value retinal anti-VEGF market.

✅ Pegfilgrastim biosimilars - including Armlupeg - approvals appearing in Nov 2025 (pegfilgrastim class / Neulasta reference), increasing options in supportive oncology care.

✅ Multiple biologics/BLA approvals and supplements (CBER lists, 2025) - FDA's 2025 biologics/BLA approval lists record a range of biologic approvals and supplements through the year (vaccine/immune globulin/ cell therapies noted among BLAs and supplements). Use FDA's 2025 Biological Approvals pages for the authoritative, up-to-date list.

EMA / European Regulatory Activity (2025):

✅ EMA continued biosimilar recommendations in 2025 (including VEGF/anti-VEGF and other monoclonal antibody classes), continuing Europe's steady stream of biosimilar marketing authorisations that expand competition in oncology and ophthalmology classes. For product-level approvals check EMA "What's new" and the biosimilar marketing-authorisation pages.

Major Mergers & Acquisitions in 2025:

✅ Intas Pharma - acquisition of UDENYCA (pegfilgrastim biosimilar) - Intas completed a transaction (reported 2025) to acquire rights/asset for UDENYCA for about $558 million, strengthening its oncology/biosimilar portfolio.

✅ Biocon (reports of strategic biosimilars business moves / potential merger) - media reporting in 2025 indicated major strategic moves and discussions around Biocon's biosimilars business (valuations reported in the ~$4.5B neighborhood in press coverage). These are strategic consolidation signals in the biosimilars sector (some items were reported as advanced discussions rather than closed deals).

✅ Celltrion - US manufacturing expansion / near-term acquisition activity (2025 reports) - Celltrion has been reported to be pursuing its first U.S. manufacturing plant acquisition to boost US manufacturing footprint for biosimilars. This reflects vertical integration / on-shore capacity moves among biosimilar leaders.

✅ Other 2025 pharma M&A that touch biosimilars/CDMO supply chains - several deals and sector consolidations reported in 2025 (CDMO takeovers, full-business acquisitions) that influence biologics manufacturing capacity and commercialization. See 2025 pharma M&A roundups for a broad list.

Major Players:

Key companies in the Biosimilars and Biologics market include:

Amgen Inc.
Johnson & Johnson
Biogen Inc.
Teva Pharmaceutical Industries Limited
Biocon Biologics Inc.
Pfizer Inc.
Celltrion, Inc.
Samsung Bioepis
AbbVie Inc.
Boehringer Ingelheim International GmbH.

Segments Covered in the Biosimilars and Biologics Market:

By Type: Biologics, Biosimilars.

By Application: Oncology, Autoimmune Diseases, Chronic Diseases, Infectious Diseases, Neurology, Ophthalmology, Others.

Regional Analysis for Biosimilars and Biologics 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 and Biologics market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Biosimilars and Biologics 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 and Biologics 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 and Biologics 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 and Biologics market?

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

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

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

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