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FDA Advisory Panel Unanimously Supports Approval Of First Trastuzumab And Bevacizumab Biosimilars

July 13, 2017
FDA’s Oncologic Drugs Advisory Committee voted unanimously Thursday (July 13) to support approval of two proposed biosimilars: Mylan's biosimilar application for Genentech's Herceptin (trastuzumab) to treat metastatic breast cancer, and Amgen's biosimilar application for Roche's Avastin (bevacizumab) to treat metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma multiforme, metastatic renal cell carcinoma and cervical cancer. Mylan’s MYL-1401O is the first application for a proposed biosimilar to Genentech’s U.S.-licensed Herceptin (trastuzumab) , which is used for the treatment of HER2...

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