FDA Accepts BLA for Alvotech and Dr. Reddy’s Denosumab Biosimilars

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.

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