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…
