Pfizer has bagged European Commission approval for its Avastin biosimilar Zirabev (bevacizumab).
The decision covers 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 approval is based on a comprehensive submission package which demonstrated biosimilarity of the drug and Roche’s Avastin.
This includes results from the Phase III REFLECTIONS B739-03 clinical comparative study, which showed equivalence and found no clinically meaningful differences between Zirabev and the originator product in patients with advanced non-squamous NSCLC.
The drug's approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in December 2018. It has also been filed for regulatory approval with the US Food and Drug Administration. (FDA).
“Pfizer is dedicated to increasing access to biosimilars for patients suffering from serious illnesses and helping create a more sustainable healthcare system,” said Andreas Penk, regional president, Oncology International Developed Markets at Pfizer.
“We are proud that Zirabev was approved today as our second oncology biosimilar in Europe. This milestone reflects our ongoing commitment to biosimilars as we continue to bring high-quality medicines to market that may help generate cost savings for cancer care.”
Pfizer has a robust portfolio of potential biosimilar candidates in mid to late stage development, with Zirabev as its fifth biosimilar approved for use in Europe.