FDA OKs First 'Biosimilar' Drug to Fight Cancer, Mvasi
THURSDAY, Sept. 14, 2017 -- The first approval of a biosimilar drug to treat cancer was announced Thursday by the U.S. Food and Drug Administration.
A biosimilar is a biological product that is approved because it is highly similar to an already-approved biologic drug and has no significant differences in safety and effectiveness from the first product, the FDA explained.
"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 health care costs and increase access to important therapies," FDA Commissioner Dr. Scott Gottlieb said in an agency news release.
Mvasi is marketed by Amgen, Inc., headquartered in Thousand Oaks, Calif.
Like Avastin, the labeling for Mvasi has a boxed warning about an 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.
Common side effects of Mvasi include nosebleeds, headache, high blood pressure, inflammation of the nasal cavity, high levels of protein in the urine, taste alteration, dry skin, rectal bleeding, excessive tear production, back pain and skin irritation, according to the FDA.
Women who are pregnant should not take Mvasi because it may cause harm to a developing fetus.
The U.S. Food and Drug Administration has more on biosimilars.
Posted: September 2017