Celltrion Healthcare announced today that the European Commission (EC) has approved Vegzelma (CT-P16), a biosimilar bevacizumab referencing EU-approved Avastin, 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.

VEGZELMA is a vascular endothelial growth factor inhibitor indicated for the treatment of...Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.

Celltrion Healthcare announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation of a bevacizumab biosimilar candidate, referencing EU-approved Avastin®, Vegzelma™ (CT-P16). The positive CHMP opinion was supported with a comprehensive data package and totality of evidence demonstrating biosimilarity to the reference product for indications including 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 therapeutic equivalence of CT-P16 and reference bevacizumab was demonstrated by way of objective response rate (ORR) during the induction study period.