CHMP recommends approval of Zirabev (bevacizumab biosimilar) for metastatic cancer.- Pfizer.

Pfizer announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for Zirabev (bevacizumab), a potential biosimilar to Avastin (bevacizumab). Zirabev is a monoclonal antibody 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 regulatory submission is supported with a comprehensive data package and evidence demonstrating biosimilarity to the originator product. This includes results from the phase III REFLECTIONS B739-03 clinical comparative study, which demonstrated clinical equivalence and found no clinically meaningful differences between Zirabev and Avastin in patients with advanced non-squamous NSCLC. As part of the overall REFLECTIONS clinical trial program, Zirabev has been studied in approximately 400 subjects.

See: A comparative clinical study of PF-06439535, a candidate bevacizumab biosimilar, and reference bevacizumab, in patients with advanced nonsquamous non-small cell lung cancer. Socinski MA., Von Pawel J., Kasahara K., et al. Abstract 109. Presented at ASCO 2018.