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FDA Approves First Avastin Biosimilar

FDA announced Thursday that it has approved Mvasi (bevacizumab-awwb), Amgen and Allergan’s biosimilar of Genentech’s Avastin (bevacizumab), a monoclonal antibody used in the treatment of a number of different cancers. Mvasi is the seventh biosimilar approved in the United States under the BPCIA and the first biosimilar approved by FDA for cancer treatment. Mvasi was approved for all six indications of Avastin that are not protected by orphan drug exclusivities, with Avastin’s other indications protected by exclusivities expiring in 2021 and 2023.

A second oncology biosimilar, Mylan and Biocon’s proposed biosimilar of Genentech’s Herceptin (trastuzumab), has struggled to gain FDA approval despite receiving a unanimous favorable recommendation from FDA’s Oncological Drugs Advisory Committee at the same July 2017 meeting as Mvasi. Last month, FDA extended the target action date for Mylan/Biocon’s application to December 3. Mylan and Biocon withdrew their application in Europe for the trastuzumab biosimilar after problems encountered during a manufacturing inspection, though they intend to resubmit the application.

Categories: Biosimilars, BPCIA, FDA
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