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Pharmaceuticals / Submissions and Approvals

FDA Approves First Cancer Biosimilar: Amgen’s Mvasi

Sept. 19, 2017
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The FDA approved the first U.S. biosimilar for the treatment of cancer, Amgen’s Mvasi, a biosimilar of the blockbuster Avastin.

Mvasi (bevacizumab-awwb) was approved for use in multiple cancer types, including certain colorectal, lung, brain, kidney and cervical cancers, some in combination with chemotherapy or other treatments.

The approval was based on structural characterizations, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other safety and effectiveness data, the FDA said.

Mvasi is the seventh biosimilar approved by the FDA, and was not approved as an interchangeable product. Previous biosimilars have included tumor-necrosis-factor-based treatments for rheumatoid arthritis, psoriasis and immune system-related diseases, namely versions of Humira (adalimumab) and Remicade (infliximab).

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