On 27 April 2026, Samsung Bioepis published its 13th US Biosimilar Market Report, which has been released every quarter since April 2023. The report provides an overview of the US biosimilar market and details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.
The Q2/2026 edition reports that, as of March 2026, the FDA has approved 92 biosimilars across 20 unique biosimilar molecules, 67 of which have been launched in the US. This is an additional 2 biosimilars approved and 3 launched since Q1/2026. The biosimilars FDA approved in Q1/2026 were Accord Biopharma’s Filkri™ (filgrastim) (referencing Amgen’s Neupogen®) and Teva Pharmaceutical’s Ponlimsi™ (denosumab) (referencing Amgen’s Prolia®) The Q1/2026 launches were Samsung Bioepis’ Ospomyv® (denosumab) (referencing Amgen’s Prolia®) and Gedeon Richter/Hikma’s Enoby® and Xtrenbo® (denosumab) (referencing Amgen’s Prolia® and Xgeva®, respectively).
Samsung Bioepis reports as “key highlights” increases in US market share of adalimumab biosimilars (to 60% as of February 2026), and ustekinumab biosimilars (an increase of 8% to 27% as of Q4/2025). The increase in adalimumab biosimilar adoption is said to reflect the inclusion of Quallent private label sales in market share calculations beginning in 2026.
The Biosimilar Market Report summarises the FDA’s October 2025 and March 2026 draft guidance regarding streamlining biosimilar development, including by indicating that Clinical Efficacy Studies (CES) are no longer expected by default and clarifying that clinical data generated using a non-US-licensed comparator product may be used to support a US biosimilar application, provided sufficient scientific justification is established. The Report concludes that reduced reliance on CES and increased flexibility in comparator sourcing “may lower development cost and complexity” and “may enable development across a broad set of reference products particularly in later-wave or smaller markets”. However, the Report refers to market research suggesting that reduced reliance on CES is unlikely to materially impact coverage or formulary positioning, as FDA approval is viewed as the threshold for equivalence.