On 23 October 2025, Samsung Bioepis published its eleventh US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.
The Q4/2025 edition reports that, as of September 2025, the FDA has approved 80 biosimilars across 19 unique biosimilar molecules, 58 of which have been launched in the US. This is an increase over Q3/2025, when there had been 75 biosimilar approvals and 52 US biosimilar launches.
The products FDA-approved since the Q3/2025 report are Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (HLX14), and Gedeon Richter/Hikma’s Enoby™ and Xtrenbo™ (RGP-14-P), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, and Biocon’s Kirsty™, biosimilar to Novo Nordisk’s Novolog® (insulin aspart). The biosimilars launched since the last report are Fresenius Kabi’s Conexxence® and Bomyntra® and Celltrion’s Stoboclo® and Osenvelt®, each denosumab biosimilars, and Dong A ST/Meiji Seika Pharma/Accord’s Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).
Key highlights from the market report are said to include:
- Only a single biosimilar competitor to Regeneron’s Eylea® (aflibercept) is currently in the US market (Amgen’s Pavblu®, launched October 2024) offering a WAC discount of -12%. However, there are 4 approved aflibercept biosimilars: Biocon’s Yesafili® (due to launch H2/2026), Formycon/Klinge’s Ahzantive® (due to launch Q4/2026), Sandoz’s Enzeevu® (due to launch Q4/2026), and Samsung Bioepis’ Opuvzi® (currently subject to pending BPCIA litigation and a preliminary injunction).
- The market share for Novartis’ Lucentis® (ranibizumab) has increased to 90%, with the pause on commercialisation of Sandoz’s biosimilar, Cimerli®. The only other ranibizumab biosimilar on the US market is Samsung Bioepis’ Byooviz®.
- As at Q4/2025, the average ASP of trastuzumab biosimilars has dropped 19% compared with Q3/2025. According to the report, this is primarily driven by a sharp decline of ASP in Accord’s Hercessi®.
The report includes insights on how payers are preparing for the implementation of the Maximum Fair Price (MFP) policy established by the Inflation Reduction Act (IRA) of 2022. The negotiated prices under the MFP for an initial tranche of ten drugs will take effect on 1 January 2026. According to comments made in the report by Dr William Fleming, a former senior Medicare executive, the introduction of MFP is expected to produce “a mixed impact on biosimilar adoption” with lower negotiated prices for reference products potentially narrowing the incentive to switch in some cases, but there potentially being accelerated uptake for biosimilars that maintain a pricing advantage or offer greater contracting flexibility.