Amgen’s bevacizumab biosimilar gains approval

The FDA has approved the first bevacizumab biosimilar (Mvasi, Amgen) for the treatment of multiple types of cancer.

Bevacizumab (Avastin) is widely used off-label for treating neovascular ophthalmic diseases. Approval of the biosimilar, which will carry the generic name bevacizumab-awwb, was based on evidence from 2 comparative clinical trials as well as extensive structural and functional characterization.

“Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies,” said FDA Commissioner Scott Gottlieb, MD. “We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness.”

Bevacizumab was approved in February 2004 and is manufactured by Genentech.