FDA Approves Zirabev, an Avastin Biosimilar, for Five Cancer Types

The Food and Drug Administration (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 Avastin. This includes results from the REFLECTIONS B7391003 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between Zirabev and Avastin in patients with advanced non-squamous NSCLC.

“Biosimilars like Zirabev can help increase access to impactful therapies, driving market competition that may ultimately lower costs and help address the diverse needs of patients living with cancer,” said Andy Schmeltz, Global President of Pfizer Oncology. “We are proud to add Zirabev to our growing oncology portfolio for U.S. patients living with a wide variety of tumor types.”

Zirabev and Avastin work 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.

“Zirabev represents a welcome addition to the treatment armamentarium in its approved indications, potentially providing physicians with a medicine that has a similar safety profile and efficacy as the reference product,” said Dr. Niels Reinmuth, Department of Thoracic Oncology, Asklepios Lung Clinic, Munich-Gauting, Germany and lead author of the REFLECTIONS study. “The FDA’s approval of Zirabev may provide an important new option for the treatment of multiple forms of cancer.”