FDA Approves Coherus BioSciences’ Udenyca Post-Chemo Autoinjector

The FDA has approved Coherus BioSciences’ Udenyca (pegfilgrastim-cbqv) pre-filled single-dose autoinjector for use at home or in a medical office, for administration the day after chemotherapy, eliminating the need to return to the chemotherapy clinic or wear an on-body device.

Udenyca is a biosimilar for pegfilgrastim, a bone marrow stimulant which helps the body make white blood cells and decrease the incidence of infection in chemotherapy patients.

The autoinjector features push-on-skin activation, “immediately and reliably delivering a complete pegfilgrastim dose,” the company said.

Coherus BioSciences plans on making the Udenyca autoinjector commercially available in the U.S. during the second quarter of this year.