FDA accepts BLA for Sandoz's Neulasta biosimilar

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said FDA accepted a BLA for LA-EP2006, a proposed biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN), a pegylated granulocyte colony-stimulating factor (G-CSF).

Sandoz spokesperson Leslie Pott declined to disclose a user fee action date for the biosimilar. ...