FDA Decision Signals New Competition For Some Of The Costliest Drugs

A look inside the factory in Kundl, Austria, where Sandoz, a unit of Novartis, makes biosimilar drugs.i

A look inside the factory in Kundl, Austria, where Sandoz, a unit of Novartis, makes biosimilar drugs.

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Novartis

A look inside the factory in Kundl, Austria, where Sandoz, a unit of Novartis, makes biosimilar drugs.

A look inside the factory in Kundl, Austria, where Sandoz, a unit of Novartis, makes biosimilar drugs.

Novartis

Mark McCamish spent more than five years preparing for a presentation he gave this winter.

McCamish is in charge of biopharmaceutical drug development at the Sandoz division of Switzerland’s Novartis. He and his colleagues made the case to a panel of 14 cancer specialists and a group of Food and Drug Administration regulators that a company drug codenamed EP2006 should be approved for sale in the U.S.

The drug, brand name Zarxio, is similar to but not quite identical to Amgen’s Neupogen, a medicine approved by the FDA back in 1991 to fight infections in cancer patients.

Industry representatives, patient advocates and

Article source: http://www.npr.org/blogs/health/2015/03/10/388668910/fda-decision-signals-new-competition-for-some-of-the-costliest-drugs?utm_medium=RSS&utm_campaign=affordablecareact

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