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FDA greenlights Pfizer biosimilar version of Genentech's Avastin

Published on 01/07/19 at 10:09am

Pfizer is celebrating the approval by the FDA of Zirabev, its biosimilar version of Genentech’s Avastin (bevacizumab), which is now approved in the US in all indications as its reference product, including 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 decision was made after the FDA reviewed supporting data, including findings from the REFLECTIONS B7391003 clinical comparative study which indicated that Pfizer’s biosimilar demonstrated “no clinically meaningful differences between Zirabev and the reference product in patients with advanced non-squamous NSCLC”.

The news marks the second oncology monoclonal antibody approval from the FDA for Pfizer, following the authorisation of Trazimera in June.

“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,” explained Andy Schmeltz, Global President, Pfizer Oncology. “We are proud to add Zirabev to our growing oncology portfolio for US patients living with a wide variety of tumour types.”

Dr Niels Reinmuth lead author of the study at the Department of Thoracic Oncology Asklepios Lung Clinic, Munich-Gauting, said:“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. The FDA’s approval of Zirabev may provide an important new option for the treatment of multiple forms of cancer.”

Matt Fellows

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