US Biosimilars Market 2025 | FDA Approvals, Oncology Growth & Advanced Biomanufacturing

The US Biosimilars Market size reached US$8.62 billion in 2024 and is expected to reach US$65.62 billion by 2033, growing at a CAGR of 25.5% during the forecast period 2025-2033, according to DataM Intelligence. This growth is driven primarily by the expiration of patents for many blockbuster biologics such as Humira, Enbrel, and Remicade, enabling more biosimilar competition to enter the market. Increasing pressure to reduce healthcare costs and rising demand for affordable treatment options for chronic and autoimmune diseases, especially in oncology, further fuel market expansion. Leading players include Pfizer, Amgen, Sandoz (Novartis), Biocon Biologics, Teva Pharmaceutical Industries, Celltrion, Samsung Biologics, Dr. Reddy's Laboratories, and Fresenius Kabi.

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Emerging opportunities in the U.S. biosimilars market include expanding indications into oncology, autoimmune disorders, and endocrinology, advancements in biosimilar manufacturing technologies allowing more complex molecules, and growing collaborations between biosimilar manufacturers and pharmaceutical companies to accelerate development and commercialization. The increasing emphasis on value-based care by payers and the inclusion of biosimilars in formularies enhance adoption rates. The oncology segment is anticipated to grow at the fastest pace due to the high cost of cancer biologics and reimbursement incentives.

Strategic Alliances and Acquisitions Driving Evolution in the US Biosimilars Sector in 2025

1. FDA Approvals and Market Expansion: The FDA approved 10 new biosimilars in Q1 2025 alone, including biosimilars for Stelara (ustekinumab), Actemra (tocilizumab), Xgeva/Prolia (denosumab), Novolog (insulin aspart), and Xolair (omalizumab). Seven of these biosimilars were launched in the US during this period, significantly expanding treatment options and competition, leading to price reductions and improved patient access.

2. Strategic Licensing and Commercial Collaborations: Organon and Henlius entered a strategic alliance to commercialize denosumab biosimilars in the US market. Similarly, Amgen secured exclusive contracts with major pharmacy benefit managers to position their adalimumab biosimilar (Amjevita) and ustekinumab biosimilar (Wezlana) for wider market penetration, driving adoption through pricing and formulary access strategies.

3. Manufacturing Capacity Expansion and Acquisitions: Biosimilar leaders like Celltrion are nearing the acquisition of manufacturing facilities in the US to bolster production capacity and speed market entry. Additionally, companies like Sandoz launched the first interchangeable denosumab biosimilars approved by the FDA in 2025, reinforcing competitive positioning in the immunology biosimilars segment.

Innovative Technological Advances Reshaping the US Biosimilars Industry in 2025

1. Advanced Manufacturing Technologies: Improved bioprocessing, cell line development, and analytical characterization methods enable faster, more cost-effective biosimilar production with high similarity to innovator biologics, including complex recombinant glycosylated proteins.
2. Expanded Therapeutic Applications: While chronic and autoimmune disorders dominate biosimilar indications, oncology is the fastest-growing sector, driven by biosimilar versions of monoclonal antibodies used in cancer treatment.
3. Regulatory and Market Access Innovations: The FDA continues to refine approval pathways, promoting greater biosimilar uptake through educational programs and incentives for healthcare providers and payers, reducing barriers to adoption.

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The United States leads the biosimilars market globally with the largest revenue share due to a well-established pharmaceutical industry, an advanced regulatory framework, and increasing biosimilar approvals by the FDA. The US benefits from strong government support aimed at reducing healthcare costs through biosimilar adoption, increased payer and provider awareness, and expanded market access supported by competitive pricing. Massive healthcare expenditure in biologics, rising prevalence of chronic diseases (e.g., cancer, autoimmune disorders), and patent expirations of blockbuster biologics create strong demand for biosimilars. The US market saw exponential growth driven by biosimilars for oncology, immunology, and endocrinology indications, with ongoing pipeline expansion expected to sustain momentum.

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This release was published on openPR.