Samsung Bioepis Co., Ltd. today released its Second Quarter 2026 Biosimilar Market Report, marking the thirteenth 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 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 Over the past year, FDA has issued two notable draft guidance updates: an October 2025 draft indicating that comparative efficacy studies (CES) may no longer be routinely expected, and a March 2026 revision introducing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, 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.”
Key highlights from market analysis:
- As of March 2026, the number of approved biosimilars in the US had reached 92 across 20 unique biological molecules, of which 67 (73%) had been launched in the market
- As of February 2026, adalimumab biosimilar adoption had increased to 60%, reflecting the inclusion of Quallent private label sales in market share calculations beginning in 20262
- As of the fourth quarter of 2025, the market share of ustekinumab biosimilars had reached 27%.3 As of the second quarter of 2026, the average ASP of ustekinumab biosimilars had declined to $753, representing a 73% decrease from the previous quarter. This sharp decline was primarily attributable to revisions in ASP calculations for several ustekinumab biosimilars, which were adjusted to reflect only the price of the initial intravenous loading dose which falls under Medicare Part B4
- Across denosumab biosimilars, WAC prices vary considerably, with discounts ranging from 6% to 79% compared to Prolia and 6% to 86% compared to Xgeva. Similarly, pricing for ustekinumab 130mg vial shows substantial variation across biosimilars, with both WAC and ASP spanning a wide range by product
- The two eculizumab biosimilars — Bkemv and Epysqli — are respectively discounted 9% and 32% below the reference product’s ASP, reflecting divergent pricing strategies
To access the Second 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. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.
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Based on February 2026 and Q4 2025 data, respectively. Both figures do not reflect the market share of some private label products whose data are not publicly available. | ||
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The total market share of adalimumab biosimilars does not reflect the market share of the two Cordavis private label products, Cordavis Humira and Cordavis Hyrimoz. | ||
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The total market share of ustekinumab biosimilars does not reflect the market share of Cordavis or Quallent private label products. | ||
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ASP is the primary methodology Medicare uses to determine payment for most drugs and biologicals covered under Part B. Up until the first quarter of 2026, the ASPs of several ustekinumab biosimilars reflected a blended ASP incorporating both the initial intravenous loading dose reimbursed under Medicare Part B and the subcutaneous maintenance dose not covered under Part B; this methodology was corrected in the second quarter of 2026. | ||
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