Samsung Bioepis Releases Third Quarter 2025 US Biosimilar Market Report Exploring the Most-Favored-Nation (MFN) Policy and its Impact on Biosimilars

• Features two in-depth topics: the Most-Favored-Nation (MFN) Policy and its potential implications for the biosimilar market and exploring the critical roles of drug quality and supply stability in the pharmaceutical sector

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today released its Third Quarter 2025 Biosimilar Market Report, marking the tenth edition of the Quarterly Biosimilar Market Report in the United States. The report offers insights into recent biosimilar pricing trends, market dynamics such as biosimilars adoption and price erosion, and the latest policy affecting biosimilars such as the Most-Favored-Nation (MFN) policy.

“When we first launched this report in Q2 2023, the US market had seen the approval of 40 biosimilars, with 28 products commercially launched. As of this tenth edition, the numbers have risen to 75 approvals and 53 launches, reflecting the market’s accelerating pace and growing complexity,” said Thomas Newcomer, Vice President, Head of US Commercial Operations, at Samsung Bioepis. “As the biosimilar landscape continues to evolve at a rapid pace, our aim remains to providing clear, data-driven insights to help our readers navigate this increasingly dynamic environment.”

Key highlights from market analysis:

• In Q2, two biosimilars were approved by the U.S. Food and Drug Administration (FDA) in the ustekinumab (1) and bevacizumab (1) markets. Four biosimilars were launched within the denosumab (2) and eculizumab markets (2).
• Comprehensively, the Average Sales Prices (ASP) of biosimilars remained 20-30% lower than reference biologics, with deeper discounts in crowded therapeutic classes, such as adalimumab and ustekinumab.
• The first part of the ‘Biosimilar Deep Dive’ explores the implications and the potential effects of the MFN policy on the US biosimilars market. Despite its uncertainty, the policy’s downward pressure on brand pricing risks and undermines the economic viability and adoption of biosimilars, ultimately limiting competition and increasing costs in the biologics market.
• The second part of the ‘Biosimilar Deep Dive’ covers how quality manufacturing and supply reliability underpin successful biosimilar partnerships and sustainable market integration. High-quality manufacturing is achieved through process consistency, rigorous testing, adherence to Current Good Manufacturing Practices (cGMP), and successful regulatory inspections. Biosimilar manufacturers can build trust by ensuring consistent supply through multi-sourcing production and a strong record of reliability and safety.

The report is part of Samsung Bioepis’ quarterly series to enhance transparency and provide objective insights into US biosimilar market evolution, after the Centers for Medicare & Medicaid Services (CMS) publishes updated quarterly ASP values for each product.

To access the Third 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.