European Commission approves Coherus’s Udenyca

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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.

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I write a weekly blog for Georgetown University’s Lombardi Comprehensive Cancer Center community. Here I share an updated version of a blog post I wrote in September 2024, now supplemented by some poems I have written over the years that inspired paintings by my wife Harriet Weiner, who is a much better artist than I am a poet or writer. 

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