Court blocks Novartis’ biosimilar copy of Amgen’s Neupogen

Amgen ($AMGN) is none too eager for Novartis ($NVS) to roll out its newly FDA-approved biosimilar version of its blockbuster Neupogen, and for now, it’s getting its way: A U.S. appeals court has blocked sales of the copycat while the companies resolve a patent dispute.

The U.S. Court of Appeals for the Federal Circuit in Washington has granted the California biotech’s request for an injunction, The Wall Street Journal reports. And that’ll keep the med–dubbed Zarxio–off the U.S. market while the court resolves Amgen’s appeal of a lower-court ruling that gave Zarxio a go-ahead to roll out.

The companies are at odds over Neupogen’s patent, which Amgen thinks Zarxio infringes. The injunction will hold up Zarxio’s launch until at least June 3–when oral arguments are scheduled–though it may take longer to resolve the case, the WSJ notes.

For Amgen, Zarxio threatens the $839 million in U.S. sales that Neupogen posted last year. And that’s key revenue for the company, whose second-best seller, Enbrel, is aging, too. The company is also in the middle of a large-scale restructuring, which will claim thousands of jobs when all is said and done.

 

But even if the knockoff does launch soon, some pharma execs–including Novartis CEO Joe Jimenez himself–think it’ll still be awhile before biosimilars take hold in the marketplace. As he told Reuters last August, doctors, patients and payers will need some time to figure out how to respond to the new therapies once they hit the scene.

Come 2020, though? “You’re going to see a big impact,” he predicted.

http://www.fiercepharma.com/story/court-blocks-novartis-biosimilar-copy-amgens-neupogen/2015-05-08?utm_medium=nl&utm_source=internal

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