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News From the Food and Drug Administration
November 7, 2017

First Biosimilar to Treat Cancer

JAMA. 2017;318(17):1644. doi:10.1001/jama.2017.15839

The FDA has approved the country’s first biosimilar for adults with cancer. Bevacizumab-awwb, which will be marketed as Mvasi, has been approved to treat the same types of cancers as its reference product, bevacizumab, which is sold as Avastin.

The drug is a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF). By blocking VEGF’s interaction with its receptors, bevacizumab-awwb prevents the development of new blood vessels that solid tumors need to thrive. Bevacizumab-awwb and bevacizumab are from different manufacturers that use their own unique cell line and proprietary processes. Differences between the 2 drugs aren’t clinically meaningful in terms of safety, purity, and potency.