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1 Jul 2019

US FDA approves Pfizer’s Biosimilar Zirabev

Pfizer Inc announced the US FDA has approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.

The FDA approval was based on review of a comprehensive data package which demonstrated biosimilarity of Zirabev to the reference product. This includes results from the REFLECTIONS B7391003 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between Zirabev and the reference product in patients with advanced non-squamous NSCLC.

Zirabev (bevacizumab-bvzr) is a mAb biosimilar of the reference product, Avastin, which works by inhibiting the formation of new blood cells (angiogenesis) by specifically recognizing and binding to vascular endothelial growth factor (VEGF) protein. As part of the REFLECTIONS clinical trial program, Zirabev has been studied in nearly 400 patients to date.

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