Riley Wyberg

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FDA Approves Fresenius’s Denosumab Biosimilars

On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), referencing Amgen’s PROLIA® and XGEVA®, respectively.  These approvals make Fresenius...more

3/28/2025  /  Amgen , Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Fresenius , Pharmaceutical Industry , Pharmaceutical Patents , Prescription Drugs

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®. ...more

3/21/2025  /  Amgen , Biologics , Biosimilars , Food and Drug Administration (FDA) , License Applications , Pharmaceutical Industry , Prescription Drugs
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