BioCentury
ARTICLE | Politics & Policy

FDA releases Purple Book for biosimilar products

September 10, 2014 2:52 AM UTC

FDA, for the first time, published a list of innovator biologics and licensed biosimilars. The list also makes a provision for future updates to designate a biologic product as interchangeable with its reference product. The new Novartis AG (NYSE:NVS, SIX:NOVN), submitted the BLA for its biosimilar version of Neupogen filgrastim G-CSF from Amgen Inc. (NASDAQ:AMGN). Last month, Celltrion Inc. (KOSDAQ:068270) submitted the first biosimilar application for a mAb to FDA (see BioCentury Extra, Aug. 11). ...