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...Epithelial ovarian, fallopian tube, or primary peritoneal cancer...in combination with carboplatin and paclitaxel, followed by VEGZELMA as a single agent, for stage III or IV disease following initial surgical resection...in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens...in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by VEGZELMA as a single agent, for platinum-sensitive recurrent disease.

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.