Posted by Michael Wonder on 01 Dec 2016
Coherus’ marketing authorisation application to European Medicines Agency for CHS-1701 (pegfilgrastim biosimilar candidate) accepted
29 November 2016 - Coherus BioSciences today announced acceptance of a marketing authorisation application to the EMA for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate.
This represents the first EMA submission and acceptance for Coherus BioSciences.
The CHS-1701 application is supported by biosimilarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta.
