Lexology January 16, 2025
On 16 January 2025, Samsung Bioepis published its quarterly US Biosimilar Market Report. The report has been released every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends.
The Q1/2025 edition reports that, as of December 2024, the FDA has approved 64 biosimilars across 17 unique biological molecules, with 41 of those biosimilars having launched in the US market. In Q4/2024, three new ustekinumab biosimilars were approved in the US (Accord Healthcare/Meiji Seika Pharma’s Imuldosa® (Oct 2024), Biocon’s Yesintek® (Dec 2024) and Celltrion’s SteQeyma® (Dec 2024).
Samsung Bioepis reports that in 2025 the industry is “set to witness the launch of biosimilars in new therapeutic areas and for new...