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Pfizer’s receives approval for Avastin’s biosimilar from FDA

Pfizer announced that it had received the approval of Zirabev (bevacizumab) from the United States Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer and 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 is based on the studies showing the bio-similarity with the reference compound and REFLECTIONS B7391001. In the trial, Zirabev showed similar clinical equivalence and no differences in clinical efficacy compared to the reference compound. In the trials, Zirabev has demonstrated the clinical similar in 400 patients.

Zirabev is a monoclonal antibody inhibiting the formation of new blood cells by binding to vascular endothelial growth factor (VEGF) protein.


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