Biosimilars, New Products

FDA commish cheers on biosimilars as Amgen, Allergan score OK for knockoff of Roche’s Avastin

Roche now has another big biosimilar rival to contend with.

The FDA has OK’d Mvasi, a knockoff of a drug that earned $3 billion in the US — $7 billion worldwide — last year as a mainstay in Roche’s drug portfolio. Amgen and Allergan — which wound up with marketing rights after it emerged on top after a series of mergers over the last 5 years — can now start lining up a launch, as the big companies scrap over the patents that expire in 2018 and 2019.

The big collaborators also recently filed for an FDA OK for a biosimilar of Roche’s Herceptin.

In what is now standard operating procedure at the FDA, regulators handed out their approval for most of the full string of label indications Roche won in the US. And there are plenty more applications for other Avastin biosimilars in the industry pipeline, as these new biosimilar plays cluster around the big franchise therapies on the market.

Novartis, meanwhile, snagged a European OK for its copy of Roche’s Rituxan in June, following Celltrion’s win on the same front.

Scott Gottlieb

The approval follows a unanimous panel recommendation in Mvasi’s favor, as well as a high-level endorsement from the agency to usher these copycats into the market as soon as possible. The growing flank attack on its big drugs also underscores the recent rash of setbacks that Roche has had to contend with, as a string of late-stage efforts have run into serious trouble at exactly the wrong moment for Roche.

“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 in a statement “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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