Reuters reports that the Food and Drug Administration has accepted an application for a bio-similar 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.
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.
The generics company already sells a biosimilar version of Amgen’s drug in more than 40 other countries, but the United States has been slower than other markets to establish a regulatory framework for biosimilars.
Better late than never as the saying goes.