BioCentury
ARTICLE | Clinical News

Biosimilar pegfilgrastim regulatory update

July 25, 2016 7:00 AM UTC

FDA issued a complete response letter to Novartis’ Sandoz Inc. generics unit for a BLA for LA-EP2006, its proposed biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN,...