FDA Approves a Biosimilar to Avastin for Cancer Treatment

The US Food and Drug Administration (FDA) has approved the first biosimilar drug for treating cancer. A biosimilar is a product that has been shown to work almost exactly like one that has already been approved. Biosimilars are approved when studies show that there are no important differences in how well they work and how safe they are. In this case, the biosimilar Mvasi (bevacizumab-awwb) works the same way as Avastin (bevacizumab).

Avastin was first approved by the FDA in 2004 and is used to treat people with certain types of colorectal, lung, brain, kidney, and cervical cancers. Avastin is a type of targeted therapy, called a monoclonal antibody, that works by interfering with blood vessels that help cancer grow. Mvasi works the same way, but is expected to be much less expensive.

The FDA based its approval of Mvasi on scientific data that show its safety and effectiveness is similar to Avastin’s. But the FDA notes that it has approved Mvasi as a biosimilar, and not as a product that is interchangeable with Avastin.  Health care providers should review prescribing information for detailed information about the approved uses.

Side effects of Mvasi are expected to be similar to those of Avastin. They include nose bleeds and inflammation of the nasal passages, headache, high blood pressure, high levels of protein in the urine, taste changes, dry skin and skin irritation, rectal bleeding, watery eyes, and back pain.

More serious potential side effects include perforations in organs (a hole made in an organ) or abnormal connections between organs, blood clots, delays in healing after surgery, bleeding, very high blood pressure, brain function problems, very high levels of protein in the urine, infusion-related reactions, and loss of ovarian function.

Like Avastin, Mvasi contains a boxed warning to alert providers and patients to the most serious side effects. Women who are pregnant should not take Mvasi.

Mvasi is marketed by Amgen, Inc. and Avastin is marketed by Genentech, Inc.

The American Cancer Society medical and editorial content team
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