Celltrion snags third oncology biosimilar approval from FDA

Sept. 28, 2022

South-Korean biopharma Celltrion announced this week that the FDA had approved its biosimilar for Roche's Avastin, Vegzelma, for the treatment of six types of cancer.

The indications approved include aggressive cancers for which there are currently limited treatment options, such as 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.

Like Avastin, Vegzelma is a recombinant humanized monoclonal antibody that has anti-cancer properties when it binds to and regulates the vascular endothelial growth factor (VEGF), which is involved in the mechanisms that help cancer cells form new blood vessels and spread. 

The approval came as a result of data that included results from a phase 3 trial in patients with metastatic or recurrent nsNSCLC. Before Vegzelma, Celltrion had won FDA approval for two other cancer biosimilars, Herzuma and Truxima. 

Avastin, first approved in 2004, has been competing with biosimilars in the U.S. since 2019, with companies like Amgen and Pfizer rolling out their versions of the product.