Biosimilar milestone passed in US as FDA panel backs filgrastim
This article was originally published in SRA
Executive Summary
A biosimilar from Novartis and its Sandoz unit has been wholeheartedly embraced by the US Food and Drug Administration's oncologic drugs advisory committee (ODAC), which voted 14-0 that the totality of evidence supported licensing for all five indications sought by the firms for their version of Amgen's Neupogen (filgrastim)1.