On March 18, 2025, Alvotech and Dr. Reddy’s announced that the FDA accepted their Biologics Licensing Application (BLA) for AVT03 (denosumab), referencing Amgen’s PROLIA® and XGEVA®. After FDA approval, Alvotech and Dr. Reddy’s expect AVT03 to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL solution and a 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.
Denosumab is a RANK ligand (RANKL) inhibitor that is used to treat bone loss.
There are currently three FDA-approved denosumab biosimilars: Sandoz’s JUBBONTI® and WYOST®, approved on March 5, 2024, Samsung Bioepis’s OSPOMYV® and XBRYK®, approved on February 13, 2025, and Celltrion’s STOBOCLO® and OSENVELT®, approved on March 3, 2025.