US Paves Way for Novartis to Copy Amgen Biotech Drug

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.

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.

Sandoz said on Thursday that overcoming the first hurdle in the approval process was an important step in increasing U.S. patient access to such treatments.

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Source: Reuters