Published on
Mar 22, 2025
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 …
Source:
JD Supra
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Label Pending
