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After FDA Approval, Amgen–Allergan Cancer Biosimilar Mvasi Faces Launch, Pricing Challenges

06:09 EDT 15 Sep 2017 | Genetic Engineering News

Amgen and Allergan have won the first U.S. approval for a biosimilar cancer treatment following FDA authorization of their Mvasi™ (bevacizumab-awwb), a near-copy of Roche subsidiary Genentech’s Avastin ® (bevacisumab). Mvasi has been approved for adults with five types of cancer, including in combination with chemotherapy for non-squamous non-small-cell lung cancer (NSCLC), in combination with chemotherapy for metastatic colorectal cancer (mCRC), glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa, and in combination with chemotherapy for persistent, recurrent, or metastatic carcinoma of the cervix. Just when Mvasi will reach the market and how much it will cost patients remain unknown. Avastin retains U.S. patent exclusivity until 2019 and European patent exclusivity until 2022. Those patents have already been at the center of a legal wrangle between Amgen and Genentech earlier this year, and the dispute may flare up again before the first prescription is dispensed.  ...

Original Article: After FDA Approval, Amgen–Allergan Cancer Biosimilar Mvasi Faces Launch, Pricing Challenges

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