US FDA: No 'meaningful' differences between filgrastim original and biosimilar
This article was originally published in SRA
Executive Summary
An investigational filgrastim biosimilar, known as EP2006, from Novartis unit Sandoz is "highly similar" to Amgen's innovator medicine Neupogen and clinical data have demonstrated there are no "clinically meaningful differences" in safety, purity and potency between the products, US Food and Drug Administration's drug reviewers said on 5 January1.