Introducing the 21st FDA Approval: Pfizer’s Zirabev, a Biosimilar of Avastin

On June 28, 2019, Pfizer announced that it had received Food and Drug Administration (FDA) approval of Zirabev™ (bevacizumab-bvzr), a biosimilar version of Roche’s Avastin®.

Pfizer approval of Zirabev

Based on the evidence provided by Pfizer, including its phase 3 trial comparing it to the EU-licensed version of Avastin, the FDA approved Zirabev for five cancer indications, including:

  • Advanced, metastatic, or recurrent nonsquamous non–small cell lung cancer
  • Metastatic colorectal cancer
  • Recurrent glioblastoma
  • Metastatic renal cell carcinoma
  • Metastatic cervical cancer

This approval does not include ovarian cancer, which is an additional indication for Avastin. Belonging to a class of biologics called vascular endothelial growth factor (VEGF) inhibitors, these agents work by preventing new development of a tumor’s blood vessels, helping to choke off growth.

Zirabev’s approval marks the 21st FDA approved biosimilar agent and the second approval for a bevacizumab biosimilar. Mvasi®, to be manufactured by the partnership of Amgen and Allergan, obtained approval in September 2017. However, this product is not yet marketed.

At a recent annual meeting of the Academy of Managed Care Pharmacy, a specialty drug pipeline expert expressed hope that Mvasi would be launched in July of this year. Its manufacturer has been embroiled in patent litigation with Roche, but the key patents are expected to expire in the immediate future.

Pfizer has not announced a launch date for Zirabev. Yet, it could be the second cancer-treating biosimilar category to enter competition (with Herceptin biosimilars) very shortly.