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 molecules such as eculizumab, aflibercept, ustekinumab and denosumab”.
According to the report, on average, biosimilar launches have resulted in 53% market share in biosimilar markets and a 53% reduction in average sales price after 5 years of biosimilar competition. The fastest uptake of biosimilars has to date occurred in oncology, ophthalmology and pegfilgrastim markets, while biosimilars in immunology, insulin glargine, filgrastim and epoetin alfa markets demonstrate slower uptake.
It is reported that, as of November 2024, the US adalimumab biosimilar market share reached 23% (up 1% since August 2024), with most gains coming from Sandoz’s Hyrimoz® and Organon’s Hadlima®. The market share for biosimilars which have had a longer time on the market include 86% for trastuzumab and 90% for bevacizumab.