Pfizer gains FDA approval of Zirabev as a biosimilar of Roche's Avastin

Pfizer on Friday announced that the FDA authorised Zirabev (bevacizumab-bvzr) as a biosimilar version of Roche's Avastin (bevacizumab), for the treatment of metastatic colorectal cancer, unresectable, locally advanced, recurrent or metastatic non-squamous non-small-cell lung cancer (NSCLC), recurrent glioblastoma, metastatic renal cell carcinoma and persistent, recurrent or metastatic cervical cancer. Zirabev gained European approval in February.  

Pfizer noted that the FDA approval of Zirabev was backed by a clinical study programme that included results from the REFLECTIONS B7391003 trial. In data announced in 2017, Zirabev was shown to be clinically equivalent to Avastin in patients with advanced non-squamous NSCLC.

Andy Schmeltz, global president of Pfizer Oncology, stated "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." In 2017, Amgen's Mvasi gained FDA approval as the first biosimilar version of Avastin.

Meanwhile, sales of Avastin reached CHF 1.8 billion ($1.8 billion) in the first quarter, reflecting year-on-year growth of 9% (for related analysis, read ViewPoints: Q1 results - How Roche is bucking the biosimilar threat in five charts).

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