Blog Big Molecule Watch September 30, 2022

Celltrion’s Bevacizumab Biosimilar Approved by FDA

Celltrion announced this week that the FDA has approved VEGZELMA (bevacizumab-adcd), a biosimilar to AVASTIN, for treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.  VEGZELMA is Celltrion’s third oncology biosimilar approved in the United States, following the approval of TRUXIMA (rituximab-abbs) and HERZUMA (trastuzumab-pkrb).  VEGZELMA was approved in the EU in August 2022, and in the UK and Japan in September 2022.

Celltrion’s VEGZELMA is the fourth 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, and Amneal’s ALYMSYS (bevacizumab-maly) in April 2022.

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