European Commission approves Zirabev (bevacizumab biosimilar) to treat the same indications as the originator product. Avastin. - Pfizer

Pfizer Inc. announced the European Commission (EC) has approved Zirabev for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma of the cervix.

The EC approval is based on a comprehensive submission package which demonstrated biosimilarity of Zirabev and the originator product. This includes results from the phase III REFLECTIONS B739-03 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between Zirabev and the originator product in patients with advanced non-squamous NSCLC. As part of the overall REFLECTIONS clinical trial program, Zirabev has been studied in approximately 400 subjects.

This approval follows the positive recommendation from the Committee for Medicinal Products for Human Use in December 2018. Zirabev has also been filed for regulatory approval with the FDA. Zirabev is a monoclonal antibody (mAb) biosimilar of the originator biologic medicine, Avastin, which works by inhibiting the formation of new blood cells (angiogenesis) by specifically recognizing and binding to vascular endothelial growth factor (VEGF) protein. Zirabev has been studied in nearly 400 patients.