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Novartis’s generic drug business Sandoz is seeking FDA approval of a copycat version of Amgen’s white-blood-cell-stimulant drug Neupogen (filgrastim). In 2013, Amgen’s combined sales of Neupogen and a longer-lasting version called Neulasta were $5.8 billion. Novartis says it is the first company to file for review under the biosimilars regulatory pathway created in the Biologics Price Competition & Innovation Act of 2009. FDA’s acceptance of the filing “represents a significant step toward making high-quality biologics more accessible in the U.S.,” says Mark A. McCamish, head of biopharmaceutical and oncology injectables development at Sandoz. The company already sells a version of filgrastim, under the name Zarzio, in more than 40 countries.
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