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Pharmaceuticals / Submissions and Approvals

Advisory Committee Unanimously Recommends Avastin, Herceptin Biosimilars

July 17, 2017
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An FDA advisory panel unanimously recommended that the agency approve two biosimilars for the cancer treatments Avastin (bevacizumab) and Herceptin (trastuzumab).

The Oncologic Drug Advisory Committee voted 17-to-0 to recommend the first candidate, Amgen’s proposed biosimilar to Avastin, developed by Genentech and Roche, for six forms of cancer.

In their presentations, Amgen and FDA representatives noted that the candidate had the same structure as Avastin as well as equivalent purity and efficacy and similar safety and immunogenicity.

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