Approved: First Biosimilar Rx for Cancer

(RxWiki News) The US Food and Drug Administration (FDA) has approved the United States’ first biosimilar drug to treat cancer.

This new medication is called Mvasi (bevacizumab-awwb). The FDA approved it as a biosimilar to Avastin (bevacizumab).

Mvasi is approved to treat several kinds of cancer, including certain types of cervical, kidney, lung, brain and colorectal cancer.

Avastin is approved to treat the same types of cancer as Mvasi. That’s because the FDA determined that Mvasi is a biosimilar medication to Avastin. Biosimilars are approved based on the fact that they are highly similar to existing medications in terms of purity, effectiveness and safety.

The FDA provided a list of expected side effects of Mvasi. These include headaches, nose bleeds, nasal cavity inflammation, high blood pressure, rectal bleeding, dry skin, excessive production of tears, skin irritation and back pain, among others. Serious side effects may include brain function problems, blood clots, loss of ovary function and others.

Mvasi will carry the same boxed warning as its reference product, Avastin. This warning notes a risk of holes in the intestines and stomach, complications with surgery and wound healing, and severe vaginal, central nervous system, gastrointestinal and pulmonary bleeding. Pregnant women and those who have recently had or will soon have surgery shouldn’t take this medication.

Talk to your doctor or pharmacist about the side effects of any new medication you’re prescribed.

Amgen manufactures Mvasi. Avastin is manufactured by Genentech.