The European Commission has granted marketing authorization to Udenyca (formerly CHS-1701), a pegfilgrastim (Neulasta) biosimilar. Udenyca is one of the first pegfilgrastim biosimilars to gain marketing authorization in Europe.
The drug is sponsored by Coherus BioSciences Inc.
Udenyca (pegfilgrastim-cbqv), formerly CHS-1701, is a growth-colony-stimulating-factor designed to decrease the chance of infection as manifested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells), in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
Udenyca drug substance manufacturing is located in Boulder, CO. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017. Udenyca is not yet available for commercial sale.
A modest proposal from a former FDA commissioner: Add antidepressants to the nation’s water supply
Warning: This is not a public health recommendation. Do not implement.