14 December 2018 - Zirabev (bevacizumab), a potential biosimilar to Avastin (bevacizumab), is Pfizer's second therapeutic oncology biosimilar to receive a positive CHMP opinion in Europe in 2018.

Pfizer today announced that the CHMP of the EMA has adopted a positive opinion, recommending marketing authorisation 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 3 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.

Read Pfizer press release