FDA Approves Fourth Avastin Biosimilar

Vegzelma is Celltrion’s third oncology biosimilar to be approved by the FDA.

The FDA has approved Celltrion Healthcare’s Vegzelma (bevacizumab-adcd), a biosimilar to Genentech’s Avastin (bevacizumab), for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

“Biosimilars have been used in many disease areas, including oncology, and have shown to be safe and effective while lowering the drug cost and increasing the access to more patients around the world,” said Professor Claire F. Verschraegen, M.D., said in a press release. She is director of the Division of Medical Oncology at the Ohio State University Comprehensive Cancer Center in Columbus.

The FDA approval of Vegzelma was based on the totality of evidence, including the pivotal phase III trial in patients with metastatic or recurrent non-squamous NSCLC. Results showed that as a first-line treatment, Vegzelma is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.

Vegzelma is Celltrion’s third oncology biosimilar approved for use 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 UK and Japan in September 2022.

Three other Avastin biosimilars have been approved by the FDA. The most recent was Amneal Pharmaceuticals’ Alymsys (bevacizumab-maly). Two other Avastin biosimilars have been approved, including Amgen’s Mvasi (bevacizumab-awwb), which was approved in September 2017, and Pfizer’s Zirabev (bevacizumab-bvzr), which was approved in June 2019.