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Novartis cancer drug gets FDA’s first ‘biosimilar’ nod
Modern Healthcare

Federal regulators have approved the first “biosimilar” drug to be sold in the U.S. under a program intended to spur a new market of lower-cost alternatives to some of the most expensive treatments in healthcare.The Food and Drug Administration on Friday approved the drug Zarxio, a cancer drug produced by Novartis unit Sandoz as a biosimilar alternative to Amgen’s biologic drug Neupogen.While many see Zarxio’s approval as a crucial first step, a number of unanswered questions may determine how big of a foothold biosimilars ultimately gain in the U.S.