On 23 July 2026, Samsung Bioepis published the 14th edition of its 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.
According to the Report, as of June 2026, the FDA had approved 96 biosimilars across 21 unique biosimilar molecules, 71 of which have been launched. Since the Q2/2026 report, the biosimilars approved are Lupin’s Ranluspec® (ranibizumab) (referencing Genentech’s Lucentis®), Bio-Thera Solutions/Accord’s Immgolis™ and Immgolis Intri™ (golimumab) (referencing Janssen’s Simponi®/Simponi® Aria), Accord’s Ennumo™ (pegfilgrastim) (referencing Amgen’s Neulasta®) and Sunshine Lake Pharma’s Langlara™ (insulin glargine) (referencing Sanofi’s Lantus®). The Q2/2026 biosimilar launches in the US were Biocon’s Bosaya® and Aukelso® (denosumab) (referencing Amgen’s Prolia® and Xgeva®).
Samsung Bioepis reports that immunology biosimilars within 5 years of launch (adalimumab, tocilizumab and ustekinumab) show strong growth in the US, with average biosimilar market penetration increasing by 25% year on year. Notably, ustekinumab biosimilar penetration is increasing at a “significantly faster pace” compared with adalimumab biosimilars, although both are immunology products “mainly covered under the pharmacy benefit”. As of Q1/2026, ustekinumab biosimilar market share had reached 42%, up 15% on the previous quarter.
FDA-approved ustekinumab biosimilars on the US market are: Amgen’s Wezlana® (FDA-approved October 2023; launched January 2025), Samsung Bioepis’ Pyzchiva® (approved July 2024, launched February 2025), Dong-A ST/Accord BioPharma’s Imuldosa® (approved October 2024; launched August 2025; added to ESI’s commercial formulary December 2025), Alvotech/Teva’s Selarsdi® (approved April 2024; launched February 2025; interchangeability status May 2025), Biocon’s Yesintek® (approved December 2024; launched February 2025), Formycon/Fresenius Kabi’s Otulfi® (approved September 2024; launched March 2025), Celltrion’s Steqeyma® (approved December 2024; launched March 2025) and Hikma’s Starjemza™ (approved May 2025; launched November 2025).