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Recent Biosimilar Approvals

On December 7, 2023, Bio-Thera Solutions, Ltd. announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN...more

12/15/2023  /  Biologics , Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

Accord BioPharma Announces the Acceptance of BLA for HLX02 (a proposed trastuzumab biosimilar) by FDA

On April 5, 2023, Accord BioPharma announced that the FDA has accepted the Biologics License Application (BLA) for HLX02 referencing HERCEPTIN (trastuzumab) for adjuvant treatment of HER2-overexpressing breast cancer and...more

4/14/2023  /  aBLA , Biologics , Biosimilars , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs
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