INCHEON, South Korea — Samsung Bioepis has released its First Quarter 2026 U.S. Biosimilar Market Report, offering an updated snapshot of biosimilar approvals, launches, pricing trends, and utilization across the United States, as well as an analysis of emerging drug pricing and reimbursement models.
The report, the twelfth edition of Samsung Bioepis’ quarterly biosimilar market analysis, reviews the status of all biosimilars available in the U.S., including approval and launch activity, Average Sales Price and Wholesale Acquisition Cost trends, and market uptake by molecule. A special Deep Dive section examines changes in U.S. Pharmacy Benefit Manager rebate contracting models and how these shifts may affect biosimilar adoption.
“As the U.S. 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 U.S. 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.”
According to the report, as of December 2025, a total of 90 biosimilars covering 20 unique biological molecules had been approved in the U.S. Of these, 63 products, representing 70 percent of approved biosimilars, had been launched commercially.
The analysis shows that biosimilar competition has driven substantial price reductions over time across multiple molecules. On average, biosimilar entry has resulted in a 52 percent decrease in Average Sales Prices within five years of the first launch, with more mature markets seeing price declines of up to 77 percent. The report notes, however, that pricing trends are not always linear, as Average Sales Prices can be influenced by strategic price repositioning and the withdrawal of certain products from the market.
In ophthalmology, the report highlights that reference aflibercept currently faces only one biosimilar competitor offering a Wholesale Acquisition Cost discount of 12 percent, despite four additional aflibercept biosimilars awaiting clearance to launch. In immunology, private-label biosimilars remain common in the adalimumab and ustekinumab markets, although most ustekinumab biosimilars have not adopted dual or high Wholesale Acquisition Cost strategies to the same extent seen in adalimumab.
Samsung Bioepis said the report is intended to help industry stakeholders better understand the evolving biosimilar landscape and the potential impact of changing pricing and contracting frameworks on market access and utilization.
Samsung Bioepis was established in 2012 and focuses on expanding access to biologic medicines through the development and commercialization of biosimilars. The company is advancing a broad pipeline across therapeutic areas including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology.
