FDA Accepts First Biosimilar Application From Sandoz
By Jeff Overley (July 24, 2014, 12:06 PM EDT) -- Novartis AG unit Sandoz Inc. announced Thursday that the U.S. Food and Drug Administration is reviewing its request to market a biosimilar version of Amgen Inc.'s Neupogen, a milestone that marks the first publicly disclosed application along an Affordable Care Act approval pathway.
The drugmaker already has clearance in more than 40 countries for its biosimilar of Neupogen, or filgrastim. The application for FDA approval comes more than four years after passage of the Biologics Price Competition and Innovation Act, an ACA section that aims to cut the costs of pricey biologic medications just as Hatch-Waxman did three decades ago for...
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