FDA approves first cancer biosimilar

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20/09/2017

The US Food and Drug Administration has approved Amgen’s Mvasi (bevacizumab-awwb) as a biosimilar to Roche/Genentech’s Avastin (bevacizumab) for the treatment of multiple types of cancer, making it the first biosimilar approved in the country for the treatment of cancer.

Mvasi is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers, and could not cut into sales of Avastin, which tottalled $6.7 billion last year. Amgen and its partner Allergan have also filed the drug for regulatory approval in the EU.

The FDA said that its approval was based on review of evidence that included extensive structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that “demonstrates Mvasi is biosimilar to Avastin”. The agency noted that it has been approved as a biosimilar, not as an interchangeable product.

“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,” said FDA Commissioner Scott Gottlieb. “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.”


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