EC approves Celltrion Healthcare’s Vegzelma for multiple cancer types

Celltrion Healthcare’s Vegzelma (CT-P16, biosimilar bevacizumab) has been approved by the European Commission (EC) for the treatment of multiple types of cancer, the company announced.

Vegzelma has been approved specifically for the treatment of metastatic breast cancer, non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer.

Vegzelma is a recombinant humanised monoclonal antibody treatment biosimilar to Genentech's Avastin (bevacizumab), which is approved in the EU.

By attaching to vascular endothelial growth factor (VEGF), Vegzelma hinders VEGF binding to its receptors Flt-1 (VEGFR-1) and kinase insert domain receptor (KDR) (VEGFR-2) on the endothelial cell surface.

Biosimilars, according to the US Food and Drug Administration (FDA), are biological products that are ‘highly similar to and have no clinically meaningful differences’ from an existing FDA-approved reference product. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower health care costs.

The EC approval is based on the ‘totality of evidence’, including a phase 3 pivotal trial in patients with metastatic or recurrent non-squamous NSCLC, which demonstrated that Vegzelma – as a first-line treatment – is highly similar to Avastin.

Commenting on the EC’s decision, Kevin Byoung Seo Choi, senior vice president and head of marketing division at Celltrion Healthcare, said: “The EC’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.”

The approval follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June this year.

Vegzelma marks Celltrion's third oncology biosimilar to receive regulatory approval in the EU, following Truxima (biosimilar to rituximab) and Herzuma (biosimilar to trastuzumab).

In September last year, the company sought regulatory approval from the FDA for Vegzelma, with the approval anticipated in the third quarter of this year.