• As of December 2025, a total of 90 biosimilars across 20 unique biological molecules had been approved in the United States, of which 63 (70%) had been launched in the market
• The Deep Dive section provides an overview of new Pharmacy Benefit Manager (PBM) contracting models for prescription drugs and their impact on biosimilar adoption

Samsung Bioepis Co., Ltd. today released its First Quarter 2026 Biosimilar Market Report, marking the twelfth edition of the Quarterly Biosimilar Market Report in the United States (US). The report provides an overview of the market status of all biosimilars available in the US, including approval and launch status, pricing (both Average Sales Price [ASP] and Wholesale Acquisition Cost [WAC]), and market uptake per molecule. The Deep Dive section in this edition provides an overview of the evolving US Pharmacy Benefit Manager (PBM) rebate contract model and how its frameworks may potentially impact the biosimilar market.

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Samsung Bioepis released its First Quarter 2026 Biosimilar Market Report, providing an overview of the market status of all biosimilars available in the US.

“As the US healthcare market enters 2026, stakeholders’ approaches to prescription drug pricing and management continue to evolve. Alongside established PBM contracting structures, new models emphasizing alternative pricing reimbursement, transparency, and a shift towards more fiduciary responsibility have emerged in response to changing market conditions,” said Thomas Newcomer, Vice President, Head of US Commercial Operations, at Samsung Bioepis. “In this quarter’s report, we provide an overview of these developments and consider how evolving PBM rebate frameworks may influence utilization patterns, including potential implications for biosimilars.”

Key highlights from market analysis:

• As of December 2025, the number of approved biosimilars in the US has reached up to 90 biosimilars across 20 unique biological molecules, of which 63 biosimilars (70%) had been launched in the market
• Biosimilar launches have led to significant price decreases over time across multiple molecules. On average, ASPs decreased by 52% within five years of the first biosimilar launch, with more mature markets achieving even greater price reductions over time (up to 77%). However, declines in ASP within certain markets do not always follow a consistent trend as they may be affected by intentional ASP repositioning and the deliberate removal of products from the market
• With four aflibercept biosimilar products awaiting clearance to launch, reference aflibercept faces only one biosimilar competitor offering a WAC discount of 12%
• In the immunology space, while private label brands remain common for adalimumab and ustekinumab, most ustekinumab biosimilars have not adopted a dual or high WAC strategy as compared to the adalimumab market

To access the First Quarter 2026 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 biologic 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 LinkedIn and X.

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Alongside established PBM contracting structures, new models emphasizing alternative pricing reimbursement, transparency, and a shift towards more fiduciary responsibility have emerged in response to changing market conditions.