The European Commission (EC) has granted approval for Celltrion Healthcare’s Vegzelma (CT-P16) to treat metastatic breast cancer, advanced and/or metastatic renal cell cancer, non-small cell lung cancer, ovarian cancer, metastatic carcinoma of the colon or rectum and cervical cancer.
Vegzelma (CT-P16) is a bevacizumab biosimilar referencing Genentech’s Avastin, which is approved in the EU.
The latest development comes after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for Vegzelma in June.
Based on the totality of findings, including those from the Phase III clinical trial of Vegzelma in metastatic or recurrent non-squamous non-small cell lung cancer patients, the EC granted approval.
According to the findings, Vegzelma as first-line therapy was found to be similar in terms of safety, efficacy and pharmacokinetics to the reference product.
An anti-cancer treatment biosimilar to Avastin, Vegzelma is a recombinant humanised monoclonal antibody which attaches to VEGF.
It thus hinders VEGF binding to its receptors Flt-1 (VEGFR-1) and kinase insert domain receptor (KDR) (VEGFR-2) on the endothelial cell surface.
Vegzelma is said to be the third oncology biosimilar of Celltrion to receive approval in the EU.
In September last year, the company sought regulatory approval from the US Food and Drug Administration (FDA ) for Vegzelma.
The approval is anticipated in the third quarter of this year.
Celltrion Healthcare senior vice-president and marketing division head Kevin Byoung Seo Choi said: “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.”