EC Grants Celltrion Avastin Biosimilar Marketing Authorization

The European Commission authorized Celltrion Healthcare’s bevacizumab biosimilar for marketing across the European Union, making it the seventh bevacizumab biosimilar to be approved in the region.

Vegzelma (CT-P16) was authorized for the treatment of metastatic breast cancer, non–small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer.

“The European Commission’s approval of Vegzelma™ will increase access to treatment for patients living with certain types of cancer at an affordable price….With proven similarities in efficacy and safety compared to the reference product Avastin®, Vegzelma™ will be available to treat some of the most commonly diagnosed cancers, which collectively affect hundreds of thousands of European patients each year,” said Kevin Byoung Seo Choi, senior vice president and head of marketing at Celltrion Healthcare.

The approval came after the European Committee for Medicinal Products (CHMP) recommended Vegzelma for authorization in June. Celltrion said that the approval was based on evidence from a phase 3 pivotal trial involving patients with metastatic or recurrent nonsquamous non–small cell lung cancer. The trial compared effects of Vegzelma with the reference product (Avastin). The results showed that as a first-line treatment, the biosimilar was “highly similar” to the originator in safety, efficacy, and pharmacokinetics.

CT-P16 is the third oncology biosimilar developed by Celltrion to be approved in the European Union. Truxima (rituximab biosimilar) and Herzuma (trastuzumab biosimilar) were approved in February 2017 and February 2018, respectively.

The biologics license application for Vegzelma is currently under review with the FDA, which is expected to make a decision on approval in the third quarter of 2022. The United States has 3 FDA-approved bevacizumab biosimilars, 2 of which are on the market.