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# FDA Approves Mvasi Biosimilar of Avastin
- URL: https://www.fdaweb.com/fda-approves-mvasi-biosimilar-of-avastin/
- Published: 2017-09-14T12:00:00.000Z
- Updated: 2026-09-14T22:50:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139628

FDA has approved Amgen’s Mvasi (bevacizumab-awwb), a biosimilar to Genentech’s Avastin (bevacizumab), for treating multiple types of cancer. It is the first biosimilar approved in the U.S. to treat cancer.

An agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576112.htm?ref=fdaweb.com) says Mvasi is approved to treat adult patients with certain colorectal, lung, brain, kidney, and cervical cancers. It says the approval was based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrate Mvasi is biosimilar to Avastin. FDA says it has been approved as a biosimilar, and not as an interchangeable product.

As with Avastin, the Mvasi labeling includes a Boxed Warning about an increased risk of gastrointestinal perforations, surgery and wound healing complications, and severe or fatal pulmonary, gastrointestinal, central nervous system, and vaginal bleeding.