On 24 April 2025, Samsung Bioepis published its ninth quarterly 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 Q2/2025 edition reports that, as of March 2025, the FDA has approved a total of 73 biosimilars across 19 unique biological molecules, with 48 of those having launched in the US market. Of note, in Q1/2025, six new ustekinumab biosimilars were launched in the US: Amgen’s Wezlana® (Jan 2025), Alvotech/Teva’s Selarsdi® (Feb 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek (Feb 2025), Formycon/Fresenius Kabi’s Otulfi® (Mar 2025) and Celltrion’s Steqeyma® (Mar 2025). According to Samsung Bioepis’ Report, ustekinumab biosimilar entrants provided steep WAC discounts of over 80%. In comparison, Amgen’s Pavblu®, the only aflibercept biosimilar available in the US at the time of the Report, launched with WAC 12% lower than that of Regeneron’s Eylea®.
The Report also outlines reviews being undertaking by US and EU regulatory agencies for the purpose of streamlining biosimilar development: in particular, the EMA’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars and the FDA’s guidance on biosimilar interchangeability.