On 23 January 2026, Samsung Bioepis published its twelfth 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 Q1/2026 edition reports that, as of December 2025, the FDA has approved up to 90 biosimilars across 20 unique biosimilar molecules, 63 of which have been launched in the US. This is an increase over Q4/2025, when there had been 80 US biosimilar approvals and 58 US biosimilar launches.
The biosimilars FDA approved in Q4 2025 were Celltrion’s Eydenzelt® (aflibercept) (approved October 2025, due to launch Q4/2026, referencing Regeneron’s Eylea®), Shanghai Henlius’ Poherdy® (pertuzumab) (approved November 2025, referencing Roche’s Perjeta®), Lupin’s Armlupeg™ (pegfilgrastim) (approved December 2025, referencing Amgen’s Neulasta®), Formycon’s Nufymco® (ranibizumab) (approved December 2025, referencing Genentech’s Lucentis®) and Accord’s Osvyrti®/Jubereq® (approved November 2025) and mAbxience’s Boncresa™/Oziltus™ (approved December 2025), referencing Amgen’s Prolia® and Xgeva® (denosumab) respectively.
The Q4/2025 US biosimilar launches were: Shanghai Henlius/Organon’s Bildyos® & Bilprevda® (denosumab) (October 2025), Celltrion’s Avtozma® (tocilizumab) (October 2025), Bio-Thera/Hikma’s Starjemza™ (ustekinumab) (November 2025) and Polpharma/Sandoz’s Tyruko® (natalizumab) (November 2025).
Samsung Bioepis reports that key highlights from the market analysis include:
- ASPs decreased by 52% (on average) within 5 years of the first biosimilar launch. More mature markets achieve greater price reductions over time (up to 77%). However, trends in ASPs within specific markets may be affected by “intentional ASP repositioning and the deliberate removal of products from the market”.
- As was the case in Q4/2025, there remains only a single biosimilar competitor to Regeneron’s Eylea® (aflibercept) in the US market (Amgen’s Pavblu®, launched October 2024) offering a WAC discount of -12%. However, there are four approved aflibercept biosimilars, which have scheduled 2026 launch dates as a result of litigation settlements: Biocon’s Yesafili® (approved May 2024, due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026) and Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026). A preliminary injunction was granted, and remains in place, preventing Samsung Bioepis’ US launch of Opuviz® (14 June 2024, upheld on appeal on 29 January 2025).
- In the immunology market, private label brands are common for adalimumab and ustekinumab, but, unlike the case for adalimumab, most ustekinumab biosimilars have not adopted a dual or high WAC strategy.
The report predicts that the evolution from rebate-driven PBM contracts to transparent and fiduciary models may present a “catalyst for widespread adoption” of biosimilars.