European Commission Authorizes Pfizer's Bevacizumab Biosimilar, Zirabev

Pfizer announced today that it has received final approval from the European Commission for its bevacizumab biosimilar, PF-06439535, to be sold under the trade name Zirabev for the treatment of certain advanced cancers: carcinoma of the colon or rectum, breast cancer, non—small cell lung cancer (NSCLC), renal cell cancer, and cervical cancer.

Bevacizumab is the company’s fifth biosimilar approved in Europe.

“Pfizer is dedicated to increasing access to biosimilars for patients suffering from serious illnesses and helping create a more sustainable healthcare system,” Andreas Penk, MD, regional president of oncology international developed markets, said in a statement. “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.”

In December 2018, the company recieve a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). The positive opinion was based on a data package that included results from the phase 3 REFLECTIONS B739-03 clinical comparative study that showed the clinical equivalence of Zirabev with the reference bevacizumab in patients with nonsquamous NSCLC. According to Pfizer, as part of the overall REFLECTIONS clinical program, the proposed biosimilar has been studied in approximately 400 individuals.

The EC decision is good for a centralized marketing authorization that will be valid in all 28 EU member states. Norway, Iceland, and Liechtenstein, members of the European Economic Area, will follow corresponding decisions based on the EC’s decision.

Pfizer has also filed for approval for the drug from the FDA.

Also approved in Europe is Amgen’s bevacizumab biosimilar, Mvasi, which was granted EC authorization in January 2018. Mvasi is also approved by the FDA, but the drug has not yet launched in either territory.