4th-qtr 2025 US biosimilar market report from Samsung Bioepis

23 October 2025

South Korea’s Samsung Bioepis 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.

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