Posted by Michael Wonder on 02 Nov 2018
U.S. FDA approves Udenyca (pegfilgrastim-cbqv)
2 November 2018 - Coherus BioSciences today announced that the U.S. FDA has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission for patients with cancer receiving myelosuppressive chemotherapy.
Udenyca is Coherus’ first drug to receive FDA or EC approval.
The approval of Udenyca was supported by a comprehensive analytical similarity package, as well as pharmacokinetic, pharmacodynamic and immunogenicity studies, including over 600 healthy subjects.
