FDA staff recommends Novartis copy of Amgen’s Neupogen

(Reuters) – Staff reviewers at the U.S. Food and Drug Administration recommended approval for Novartis AG’s copy of Amgen Inc’s blockbuster cancer drug Neupogen. Novartis’s drug is the first to be reviewed in the United States under the so-called biosimilar pathway. The reviewers found no “clinically meaningful differences” between the two drugs, the FDA said. (http://1.usa.gov/1DoT7eb) The injectable biotech medicine is designed to prevent infections in breast cancer patients undergoing chemotherapy, which reduces white blood cells, giving rise to a condition called neutropenia. …
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