Pfizer has won European Commission approval for its Avastin biosimilar Zirabev (bevacizumab).
The approval comes on the back of data from the phase III REFLECTIONS B739-03 clinical comparative study which showed equivalence and no clinically meaningful differences between Zirabev and the originator product in advanced non-small cell lunger cancer (NSCLC).
The approval covers treatment for metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced metastatic or recurrent NSCLC, advanced and metastatic renal cell cancer and persistent recurrent or metastatic carcinoma of the cervix.
Pfizer has also filed the drug for regulatory approval with the US Food and Drug Administration (FDA).
Andreas Penk, regional president of oncology, said: “Pfizer is dedicated to increasing access to biosimilars for patients suffering from serious illnesses and helping create a more sustainable healthcare system.
“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.”
Zirabev is currently Pfizer’s fifth biosimilar to be approved in Europe.