Novartis can sell copycat of Amgen’s Neupogen in September, court rules

FDA

Novartis AG’s Sandoz unit may begin selling the first copy of Amgen Inc.’s cancer treatment Neupogen as soon as Sept. 2 after an appeals court ruling Tuesday rejected arguments that it failed to follow regulatory rules.

Sandoz didn’t violate the rules when applying to sell its drug, Zarxio, the U.S. Court of Appeals for the Federal Circuit in Washington said in an opinion posted on its electronic docket. It’s the first time the appeals court specializing in patent law has applied rules for copying drugs derived from living organisms.

The case centered on interpreting a 2010 law for approving copies of biologic drugs, known as biosimilars. Sandoz in March was the first company to get U.S. Food and Drug Administration approval for such a drug, and the appeals court decision will help guide other drugmakers’ applications.

The appeals panel ordered the case sent back to the trial judge in San Francisco to consider whether Zarxio infringes an Amgen patent for use of filgrastim, Neupogen’s active ingredient.

For more details, go to: http://www.bloomberg.com/news/articles/2015-07-21/amgen-loses-appeals-court-ruling-in-bid-to-stop-novartis-drug

Michael Wonder

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Michael Wonder

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