Pfizer has cleared a major hurdle towards bringing biosimilar bevacizumab to the US market by obtaining approval from the Food and Drug Administration for its Zirabev (bevacizumab-bvzr) alternative to Genentech’s Avastin oncology brand. But significant patent barriers remain.
Based on a data package that included a read-out from its ‘Reflections B7391003’ comparative clinical trial, Pfizer has secured FDA approval for Zirabev 100mg/4ml and 400mg/16ml single-dose vials for treating five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell
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