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Amgen › Prescription Drugs › License Applications

Goodwin

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

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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®. ...more

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