ARTICLE
24 April 2025

FDA Approves Biocon Biologics' Bevacizumab Biosimilar

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Goodwin Procter LLP

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On April 10, 2025, Biocon Biologics Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved JOBEVNE™ (bevacizumab-nwgd)...
United States Food, Drugs, Healthcare, Life Sciences

On April 10, 2025, Biocon Biologics Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved JOBEVNE" (bevacizumab-nwgd), a new bevacizumab biosimilar referencing Genentech's AVASTIN®. JOBEVNE" is a recombinant humanized monoclonal antibody that acts as a vascular endothelial growth factor inhibitor. It is indicated for the treatment of certain types of colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, and primary peritoneal cancers.

Approved in 2021 in both Canada and Europe, Biocon's bevacizumab biosimilar is already available in both markets under the name ABEVMY. JOBEVNE" is Biocon Biologics' seventh biosimilar approved in the United States, joining an oncology portfolio that includes biosimilars OGIVRI® (trastuzumab-dkst) and FULPHILA® (pegfilgrastim-jmdb).

JOBEVNE" is the sixth bevacizumab biosimilar approved in the United States, following approval of Amgen's MVASI® (bevacizumab-awwb) in Sept. 2017, Pfizer's ZIRABEV" (bevacizumab-bvzr) in June 2019, Amneal Pharmaceuticals' ALYMSYS® (bevacizumab-maly) in April 2022, Celltrion's VEGZELMA® (bevacizumab-adcd) in September 2022, and Bio-Thera Solutions' AVZIVI® (bevacizumab-tnjn) in December 2023.

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