US approves first biosimilar for treating cancer

US approval for Venclexta plus Rituxan for previously treated CLL
Credit: Hurst Photo

Mvasi has become the first biosimilar approved in the United States for the treatment of cancer.

The FDA approved the Avastin biosimilar for treating multiple types of cancer – certain colorectal, lung, brain, kidney and cervical cancers – in adults patients.

The approval is based on the FDA’s review of evidence that included clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Mvasi is biosimilar to Avastin.

It has been approved as a biosimilar, not as an interchangeable product.

Common expected side effects of Mvasi include nose bleeds, high blood pressure, dry skin, rectal bleeding, excessive tear production, back pain and skin irritation, among others.

Avastin was originally approved in February 2004 and is manufactured by Genentech.