On 11 July 2024, Samsung Bioepis released its sixth US Biosimilar Market Report. The report, which has been published every quarter since April 2023, details average sales price information for US launched biosimilars and market share and price trends.
The Q3 2024 Report notes that, as of June 2024, the FDA has approved 57 biosimilars across 17 unique molecules. Of these, eight new biosimilars have been approved in the US in the last quarter: Samsung Bioepis’ Pyzchiva® and Alvotech/Teva’s SelarsdiTM (Stelara®, ustekinumab); Accord Biopharma’s HercessiTM (Herceptin®, trastuzumab), Samsung Bioepis’ Opuviz, Biocon’s YesafiliTM and Formycon/Klinge’s Ahzantive® (Eylea®, aflibercept), Amgen’s Bkemv® (Soliris®, eculizumab) and Tanvex’s Nypozi® (Neupogen®, filgrastim).
Samsung Bioepis reports that 39 of the 57 approved biosimilars have launched in the US and 14 have received an interchangeability designation.
The report tracks the impact of various biosimilars and finds that Humira®’s share of the adalimumab market dropped to 82% in May 2024, a reduction of 13% since March 2024, with most biosimilar gains coming from Sandoz’s Hyrimoz®, marketed under a Cordavis private label. The first adalimumab biosimilar was launched in the US in January 2023 (Amjevita™, Amgen) and multiple additional biosimilars entered the market in July 2023.