Samsung Bioepis Releases Fourth Quarter 2025 US Biosimilar Market Report Providing Annual Biosimilar Trends and Future Market Trajectory

• As of September 2025, the number of approved biosimilars in the US reached up to 80 biosimilars across 19 unique biological molecules – of which 58 (73%) biosimilars have launched in the market
• Market share for the reference ranibizumab has soared to 90% with the pause of a biosimilar product
• The deep dive section highlights an interview with William Fleming, a former senior Medicare executive, on Maximum Fair Price (MFP) and its potential impact on the biosimilar market in the future

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today released its Fourth Quarter 2025 Biosimilar Market Report, marking the eleventh edition of the Quarterly Biosimilar Market Report in the United States (US). The report overviews the market status of all the biosimilars that are available in the US including approval and launch status, pricing (both Average Sales Price; ASP and Wholesale Acquisition Cost; WAC) after the Centers for Medicare & Medicaid Services (CMS) publishes updated quarterly ASP values for each product, and market uptakes per molecule. This issue features an interview with Dr. William Fleming, a former senior Medicare executive, on how payers are preparing for the upcoming implementation of the Maximum Fair Price (MFP) policy. As part of the Inflation Reduction Act (IRA), the CMS has been negotiating prices for some drugs with the highest Medicare expenditures. The newly negotiated prices of the first 10 selected drugs will become effective as of January 1, 2026.

“With this report, we bring 2025 to a close — a year once again marked by extraordinary change and progress within the biosimilar landscape. From evolving policy discussions to dynamic market movements, the past year has highlighted both the opportunities and the challenges facing our industry,” said Thomas Newcomer, Vice President, Head of US Commercial Operations, at Samsung Bioepis. “Looking ahead, it is clear that 2026 will bring further shifts, with key developments expected to transform the environment in which we operate. As always, we remain committed to delivering timely insights on the critical developments shaping the biosimilar market.”

Key highlights from market analysis:

• As of September 2025, the number of approved biosimilars in the US reached 80 biosimilars across 19 unique biological molecules, of which 58 (73%) biosimilars have launched in the market
• With four biosimilar products awaiting clearance to launch, aflibercept only faces one biosimilar competitor offering a WAC discount of -12%
• As of the fourth quarter 2025, the average ASP of trastuzumab biosimilar products has dropped 19% compared to the last quarter, mainly driven by a sharp decline of ASP in a single trastuzumab biosimilar product
• The latest biosimilar entrant in the filgrastim market has shown consistent growth by capturing a 10% market share by the second quarter of 2025
• Market share for the reference ranibizumab has soared to 90% with the pause in availability of a biosimilar product

To access the Fourth Quarter 2025 Samsung Bioepis Market Report, please visit HERE.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.