FDA approves first biosimilar cancer treatment

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FDA approves first biosimilar cancer treatment

By David Salazar - 09/14/2017

SILVER SPRING, Md. — The Food and Drug Administration has approved the first biosimilar approved to treat cancer, Amgen’s Mvasi (bevacizumab-awwb), a biosimilar of Avastin.

“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,” FDA commissioner Dr. Scott Gottlieb said. “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 drug is indicated to treat five types of cancer, including in combination with chemotherapy for non-squamous non-small cell lung cancer, in combination with chemotherapy for metastatic colorectal cancer, glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa and in combination with chemotherapy for persistent, recurrent, or metastatic carcinoma of the cervix.

"The approval of Mvasi marks a significant milestone for healthcare practitioners and patients as the first anti-cancer biosimilar approved in the United States," Amgen EVP research and development Dr. Sean Harper said. "With decades of experience in oncology and biologics, Amgen continues to expand its biosimilar and oncology portfolios, and Mvasi has the potential to advance access to high-quality, targeted cancer therapy.”