On 3 March 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has accepted for review their aBLA for two new denosumab biosimilars referencing Amgen’s Prolia® and Xgeva®. The FDA has assigned a target action date in Q4 2025.
The biosimilars are being co-developed, with mAbxience responsible for the development and manufacturing and Amneal pursuing regulatory approval and having exclusive US commercialisation rights. The two companies also collaborate on Alymsys®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), which was approved in the US in April 2022.
There are three denosumab biosimilars approved in the US: Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).
There are also a number of denosumab biosimilars in the wings, with the FDA having accepted applications for review, including for: Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024). Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).