On March 3, 2025, Amneal announced FDA acceptance of its Biologics License Application (BLA) for two proposed denosumab biosimilars referencing Amgen’s PROLIA® and XGEVA®. According to Amneal, the FDA has set a target action date in Q4 2025. Denosumab is a RANK ligand (RANKL) inhibitor that is used to treat bone loss.
As previously reported, mAbxience will develop and manufacture the two denosumab biosimilars, and Amneal will pursue regulatory approval and has exclusive commercialization rights in the United States.
There are currently three FDA-approved denosumab biosimilars: Sandoz’s JUBBONTI® and WYOST®, approved on March 5, 2024, Samsung Bioepis Co., Ltd.’s OSPOMYV® and XBRYK®, approved on February 13, 2025, and Celltrion’s STOBOCLO® and OSENVELT®, approved on March 3, 2025.