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# Celltrion Gains Avastin Biosimilar Approval
- URL: https://www.fdaweb.com/celltrion-gains-avastin-biosimilar-approval/
- Published: 2022-09-28T12:00:00.000Z
- Updated: 2026-09-14T18:01:08.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152834

FDA has approved a Celltrion BLA for Vegzelma (bevacizumab-adcd), a biosimilar to Genentech’s Avastin (bevacizumab), for treating six cancer types: 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.

The company says the biosimilar’s approval was based on the totality of evidence, including a pivotal Phase 3 trial in patients with metastatic or recurrent nsNSCLC. “Results showed that as a first-line treatment, Vegzelma is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics,” it says.

Vegzelma is described as a recombinant humanized monoclonal antibody which binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, which inhibits the binding of VEGF to its receptors VEGFR-1 and VEGFR-2 on the surface of endothelial cells.