Posted by Michael Wonder on 20 Feb 2019
Pfizer receives European approval for Zirabev (bevacizumab), a biosimilar to Avastin
19 February 2019 - Pfizer today announced the European Commission 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, 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 3 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.3 As part of the overall REFLECTIONS clinical trial program, ZIRABEV has been studied in approximately 400 subjects.
