Σάββατο, 15 Ιουλίου 2017

BIOSIMILARS BEVACIZUMAB AND TRASTUZUMAB APPROVED BY FDA

On July 13, the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilar versions of bevacizumab (Avastin) and trastuzumab (Herceptin).
In the morning session, ODAC members voted 17-0 in favor of approving Amgen's bevacizumab biosimilar candidate, ABP 215, for six of bevacizumab's indications. However, the committee did not consider whether Amgen's data would support approval for two of bevacizumab's indications for ovarian cancer, as they are covered by orphan drug exclusivity until 2021 and 2023.
In the afternoon session, ODAC members voted 16-0 in favor of approving Mylan's trastuzumab biosimilar candidate, MYL-1401O, for all of Herceptin's indications, including an indication for metastatic gastric cancer, which is protected by orphan drug exclusivity through October 20, 2017.


In both cases, ODAC and FDA reviewers found there were no clinically meaningful differences between the reference products and the biosimilars, though some panel members expressed concerns about extrapolating data from studies in a single disease to multiple indications. 

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