The Center for Biosimilars Staff

FDA Launches Searchable Database Intended to Replace Static Purple Book Lists

February 24, 2020

Ultimately, the Purple Book is supposed to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products.

Coherus, Accord Both Receive Positive CHMP Opinions for Pegfilgrastim Biosimilars

July 27, 2018

Drug maker Coherus announced today that it has received a positive opinion on its pegfilgrastim biosimilar, CHS-1701, from the European Medicines Agency’s Committee for Human Use (CHMP). Coherus plans to sell the drug under the name Udenyca. Separately, Accord Healthcare received a positive opinion for its own pegfilgrastim biosimilar, which it plans to market as Pelgraz.