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  • Regulatory NewsRegulatory News

    FDA Panel Unanimously Backs Avastin and Herceptin Biosimilars

    The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously backed the approval of biosimilar versions of two of Roche's top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab). In the morning session, ODAC members voted 17-0 in favor of approving Amgen's Avastin biosimilar candidate, ABP 215, for six of Avastin's indications. However, the committee did not consider whether Amgen's data would support a...