On 10 October 2024, Samsung Bioepis released its quarterly US Biosimilar Market Report. The report has been published every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends.
The Q4 2024 edition reports that, as of September 2024, the FDA has approved 61 biosimilars across 17 unique biological molecules, 41 of which have launched in the US market. There were four new biosimilars approved by the FDA in the last quarter: Samsung Bioepis’ Epysqli™/SB12 (Soliris®, eculizumab), Amgen’s Pavblu™/ABP 938 and Sandoz’s Enzeevu™ (Eylea®, aflibercept) and Formycon/Fresenius Kabi’s Otulfi™ (Stelara®, ustekinumab).
The report tracks the impact of US biosimilars and finds that the US adalimumab biosimilar market share reached 22% as of August 2024, largely driven by the uptake of biosimilars through private label brands. It also reports that two tocilizumab biosimilars (vial formulation only) entered the US market in Q2 2024, Biogen/Bio-Thera’s Tofidence® and Fresenius Kabi’s Tyenne®, at Wholesale Acquisition Cost discounts of -16% (US$2,200) and -26% (US$1,960) respectively, compared to Roche’s Actemra® (US$2,656).
Samsung Bioepis cites data reporting that, from 2015-2023, total US biosimilar savings are US$36billion, with a third of those savings occurring in 2023.