The US Food and Drug Administration (FDA) has approved United States-based Pfizer's Zirabev (bevacizumab-bvzr), an oncology biosimilar to Roche's Avastin (bevacizumab), it was reported yesterday.
Pfizer stated that the product has been approved to treat five types of cancer, 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 approval was based on evaluation of a comprehensive data package that indicated biosimilarity of Zirabev to the reference product. The data package includes results from the Reflections B7391003 clinical comparative study, which showcased clinical equivalence and found no clinically meaningful differences between ZIRABEV and the reference product in patients with advanced non-squamous non-small cell lung cancer, according to the company.
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