By: IPP Bureau
Last updated : April 28, 2026 8:06 am
Q2 2026 analysis shows expanding approvals, stronger uptake, and a shift toward evidence-driven biosimilar evaluation
Samsung Bioepis has released its Second Quarter 2026 Biosimilar Market Report, the thirteenth edition of its quarterly analysis focused on the United States.
The report outlines the current landscape of all biosimilars available in the US, covering approval and launch status, pricing benchmarks—such as Average Sales Price (ASP) and Wholesale Acquisition Cost (WAC)—as well as market uptake by molecule.
“The regulatory environment for biosimilar approval continues to evolve. Over the past year, FDA has issued two notable draft guidance updates: an October 2025 draft indicating that comparative efficacy studies (CES) may no longer be routinely expected, and a March 2026 revision introducing additional flexibility in the use of non-US-licensed comparator data. Together, these updates reflect a broader shift toward greater emphasis on analytical and pharmacokinetic evidence in demonstrating biosimilarity,” said Thomas Newcomer, Senior Vice President and Head of US Commercial at Samsung Bioepis. “In this quarter’s report, we review these regulatory developments and assess the potential implications for biosimilar development in the US market. We also highlight perspectives from recent payer and provider market research to provide additional context on how these developments may be perceived across stakeholders.”
According to the report, as of March 2026, 92 biosimilars had been approved in the US across 20 distinct biological molecules, with 67 of them—representing 73%—already launched.
Adoption of adalimumab biosimilars reached 60% as of February 2026, a rise attributed in part to the inclusion of Quallent private label sales in market share calculations starting this year.
In the ustekinumab segment, biosimilars accounted for a 27% market share by the fourth quarter of 2025. By the second quarter of 2026, the average ASP for these products had dropped to $753, marking a 73% decline from the previous quarter. This decrease was largely driven by revisions in ASP calculations for several products, reflecting only the price of the initial intravenous loading dose reimbursed under Medicare Part B.
Pricing dynamics for denosumab biosimilars show wide variability, with WAC discounts ranging from 6% to 79% compared to Prolia and 6% to 86% compared to Xgeva. Similarly, ustekinumab 130 mg vial pricing demonstrates significant variation across biosimilars, with both ASP and WAC differing considerably between products.
For eculizumab biosimilars, Bkemv and Epysqli are priced at 9% and 32% discounts, respectively, compared to the reference product’s ASP, highlighting differing pricing approaches within the segment.
The report also examines evolving regulatory trends and incorporates insights from payer and provider research, offering a broader view of how biosimilar adoption and development may progress in the US.