First biosimilar to treat cancer approved by FDA

The US Food and Drug Administration (FDA) has approved Mvasi (bevacizumab-awwb) as a biosimilar to the cancer treatment Avastin (bevacizumab). This represents the first biosimilar approved by the regulatory body for cancer treatment.

“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 Dr Scott Gottlieb. “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.”

The FDA’s approval has been based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data demonstrating Mvasi is biosimilar to Avastin. It has been approved as a biosimilar, not as an interchangeable product.

Mvasi has been approved for the treatment of certain colorectal, lung, brain, kidney and cervical cancers. The FDA states that healthcare professionals should review the prescribing information set out in the product’s labelling carefully for the detailed information about the approved uses. Similar to Avastin, the drug will be labelled with a boxed warning to alert healthcare professionals and patients about a potential increased risk of holes in the stomach and intestines, surgery and wound healing complications and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal bleeding.

Approval for Mvasi has been granted to Amgen.