European Commission approves Coherus’s Udenyca

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

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.

Table of Contents

YOU MAY BE INTERESTED IN

The long-awaited results from the RASolute 302 trial—a phase III clinical trial evaluating daraxonrasib, a RAS inhibitor, for the treatment of patients with previously treated, metastatic pancreatic ductal adenocarcinoma—have been read out. 
At a lecture at Yale Cancer Center recently, Robert A. Winn brandished a copy of a 32-year old booklet titled “Cancer at a Crossroads: A Report to Congress for the Nation,” using it as a show-and-tell prop in arguing that America’s cancer program is once again at a crossroads and therefore in urgent need of strategic thinking (The Cancer Letter, April 10, 2026).

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login