Amgen and Allergan win FDA nod for biosimilar of Avastin, Roche's $3B seller

Amgen Headquarters
Amgen is the first to get FDA approval for a biosimilar of a cancer drug with the agency giving its OK to Mavsi, a copy of Roche $3 billion seller Avastin.

The FDA has ushered in a new era in lower cost cancer medicines with its approval of Amgen’s and Allergan's Mvasi, a biosimilar of Roche’s blockbuster drug Avastin.

The agency Thursday gave the biosimilar approval in each of Avastin’s approved indications, which include treating colorectal, lung, brain, kidney and cervical cancers.

“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 in the announcement.

RELATED: Roche's hold on Avastin, Herceptin sales loosens as FDA panel backs Amgen and Mylan biosims

The green light comes after an FDA advisory committee in July found the drug bioequivalent and voted 17-0 to recommend approval. Ahead of the vote, FDA reviewers concluded that the “totality of evidence” showed the lung cancer data could be extrapolated into Avastin’s other indications. Also like Avastin, the Mavsi label will carry a Boxed Warning for a variety of possible side effects.

The FDA decision also issues in a new era for Roche, as Amgen and partner Allergan will work to capture as much of the $3 billion in sales the drug raked in from the U.S. last year. Roche has been fighting the attack on its cancer drug juggernaut with patent battles but faces more of the same from other drugmakers. 

On the same day that the advisory committee considered Amgen's drug, it voted 16-0 in favor of a biosimilar of Roche’s Herceptin from Mylan and partner Biocon. That was also slated to get an FDA decision this month but Biocon recently reported that the FDA told Mylan it was extending the target action date for their Trastuzumab application to Dec. 3 in order to review some “clarificatory information.” Biocon said in the filing that the extension would not affect its timetable for getting the product to market in the U.S.

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