U.S. paves way for Novartis to copy Amgen biotech drug

July 24, 2014 10:32 AM

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U.S. paves way for Novartis to copy Amgen biotech drug

(Reuters) - U.S. regulators have accepted an application by Sandoz - the generics arm of Novartis - seeking approval for a copycat version of Amgen's drug Neupogen, or filgrastim, for patients with low white blood cell counts.

The Food and Drug Administration's decision to accept the filing under a new pathway for so-called biosimilar drugs marks a milestone in the rollout of cheaper copies of injectable biotech medicines in the United States.

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