European Commission Approved Celltrion Healthcare’s Bevacizumab Biosimilar

The European Commission (EC) has approved Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin, developed by Celltrion Healthcare. Celltrion Healthcare has announced that, the European Commission (EC) has approved Vegzelma (CT-P16), its biosimilar to be bevacizumab, referencing the Avastin approved by the European Union (EU).

This European approval covers the use of Vegzelma in the treatment of European patients with metastatic breast cancer, non-small cell lung cancer, advanced and metastatic renal cell cancer, and cervical cancer.

This decision of the European Commission follows the recommendation for marketing authorization that was issued by the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA).  

Kevin Byoung Seo Choi, head of marketing division and senior vice-president at Celltrion Healthcare, said the approval of Vegzelma by the European Commission will increase access to the treatment for patients living with certain types of cancer at an affordable rate.

He also said that with the proven similarities in safety and efficacy compared to the reference product Avastin, Vegzelma will be available to treat some of the most commonly diagnosed cancers that collectively affect hundreds of patients in Europe every year.