Novartis discloses CRL for Neulasta biosimilar

In 2Q16 results announced Tuesday, Novartis AG (NYSE:NVS; SIX:NOVN) said its Sandoz unit received a complete response letter from FDA for LA-EP2006, its proposed biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). The company said it is working with FDA "to address remaining questions."

On a conference call Tuesday, Novartis CMO and Head of Drug Development Vasant Narasimhan declined to comment on the details of the letter, including whether FDA raised issues with manufacturing, data or labeling. He said the company received the letter in late June, and is working with FDA to clarify a new timeline for the biosimilar. ...