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

A year ago, when he was sworn in as director of the National Cancer Institute, Anthony G. Letai set a goal: Reassure cancer researchers that the institute will keep a steady course aimed at finding treatments for cancer.
Michael R. Caputo, a cancer survivor and a Republican political operative with a wide-ranging resume, was named to the President’s Cancer Panel, a board formed under the National Cancer Act to monitor the National Cancer Program and report to the president about “barriers to progress in reducing the burden of cancer.”
For over two decades, the ASCO Genitourinary Cancers Symposiumhas stood as the premier global event that has helped advance cancer science and transform care. The 2027 Symposium will continue this legacy from Feb. 11–13 in San Francisco by bringing together the largest international audience in GU oncology to help define tomorrow’s standards of care. 

Never miss an issue!

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

Login