FDA News

FDA approves Zirabev, biosimilar to Avastin

The FDA approved bevacizumab-bvzr for the treatment of metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic nonsquamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.

Bevacizumab-bvzr (Zirabev, Pfizer) — a biosimilar to bevacizumab (Avastin, Genentech) — inhibits angiogenesis by recognizing and binding to the vascular endothelial growth factor (VEGF) protein. Biosimilars are biological products that have been shown to be highly similar to an already-approved biological product, with no clinically meaningful differences in effectiveness or safety.

“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,” Andy Schmeltz, global president of Pfizer Oncology, said in a press release. “We are proud to add Zirabev to our growing oncology portfolio for U.S. patients living with a wide variety of tumor types.”

The approval was based, in part, on review of a comprehensive data package, including results from the REFLECTIONS B7391003 clinical comparative study, which showed clinical equivalence and no clinically meaningful differences between bevacizumab-bvzr and the reference product among patients with advanced nonsquamous NSCLC.

“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,” Niels Reinmuth, MD, PhD, thoracic oncologist at Asklepios Lung Clinic in Munich-Gauting, Germany, and lead author of the REFLECTIONS B7391003 study, said in the release. “The FDA’s approval of Zirabev may provide an important new option for the treatment of multiple forms of cancer.”

This is the second biosimilar to Avastin. The first, bevacizumab-awwb (Mvasi, Amgen), received FDA approval in 2017, but has not yet been launched in the U.S. market.

The FDA approved bevacizumab-bvzr for the treatment of metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic nonsquamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.

Bevacizumab-bvzr (Zirabev, Pfizer) — a biosimilar to bevacizumab (Avastin, Genentech) — inhibits angiogenesis by recognizing and binding to the vascular endothelial growth factor (VEGF) protein. Biosimilars are biological products that have been shown to be highly similar to an already-approved biological product, with no clinically meaningful differences in effectiveness or safety.

“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,” Andy Schmeltz, global president of Pfizer Oncology, said in a press release. “We are proud to add Zirabev to our growing oncology portfolio for U.S. patients living with a wide variety of tumor types.”

The approval was based, in part, on review of a comprehensive data package, including results from the REFLECTIONS B7391003 clinical comparative study, which showed clinical equivalence and no clinically meaningful differences between bevacizumab-bvzr and the reference product among patients with advanced nonsquamous NSCLC.

“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,” Niels Reinmuth, MD, PhD, thoracic oncologist at Asklepios Lung Clinic in Munich-Gauting, Germany, and lead author of the REFLECTIONS B7391003 study, said in the release. “The FDA’s approval of Zirabev may provide an important new option for the treatment of multiple forms of cancer.”

This is the second biosimilar to Avastin. The first, bevacizumab-awwb (Mvasi, Amgen), received FDA approval in 2017, but has not yet been launched in the U.S. market.

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