BioCentury
ARTICLE | Clinical News

Zioxtenzo regulatory update

February 3, 2017 8:40 PM UTC

EMA's CHMP said Novartis withdrew its MAA for Zioxtenzo, its biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.). Pegfilgrastim is a pegylated G-CSF. Last year, FDA issued a complete response letter to Novartis for a BLA for the product (see BioCentury, July 25, 2016)...