Riley Wyberg

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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

Regulatory and Commercial Updates on Bio-Thera’s BAT2506 (golimumab)

​​​​​​​On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of...more

2/11/2025  /  Biologics , Biosimilars , European Medicines Agency (EMA) , Food and Drug Administration (FDA) , Intellectual Property Protection , IP License , Life Sciences , Pharmaceutical Industry , Regulatory Approval

FDA Approves Celltrion’s AVTOZMA (tocilizumab-anoh)

​​​​​​​On January 31, 2025, Celltrion announced that the FDA approved its tocilizumab biosimilar, AVTOZMA® (tocilizumab-anoh), referencing Genentech’s ACTEMRA®....more

2/4/2025  /  Biologics , Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs
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