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

By Beth Wang / July 13, 2017 at 8:39 PM
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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