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In historic move, FDA approves 1st biosimilar to treat cancer
  • By Marian Chu
  • Published 2017.09.15 11:40
  • Updated 2017.09.15 11:40
  • comments 0

The U.S. Food and Drug Administration Thursday marked a new page in cancer treatment by approving Amgen’s biosimilar Mvasi to treat multiple forms of cancer.

Mvasi (bevacizumab-awwb) is a biosimilar to Genentech Roche's billion dollar drug Avastin (compound: bevacizumab) and the first biosimilar to gain FDA approval to treat cancer, the regulatory body said.

Industry experts are citing the approval as one that is ushering in a new era of cancer treatment with lowered drug costs.

“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 Scott Gottlieb said.

Mvasi can now be used to treat particular colorectal, lung, brain, kidney and cervical cancers, the agency said.

Source: FDA

“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,” Gottlieb added.

The FDA issued the approval after examining extensive evidence that demonstrated the drug to be similar to Avastin, the agency said. It approved Avastin in February 2004.


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