Coherus: FDA Turns Away Udenyca On-Body Due to Filler Issues
By Colin Kellaher
Coherus BioSciences on Monday said the U.S. Food and Drug Administration has turned away its application seeking approval of an on-body injector presentation of its Udenyca drug due to issues at a third-party filler.
The Redwood City, Calif., biopharmaceutical company said the FDA issued a so-called complete response letter, indicating that it wouldn't approve the application in its current form.
Coherus said the rejection stems from an ongoing review of inspection findings at the unnamed third-party filler, adding that it will work with the filler to address the issues and resubmit the application as quickly as possible.
Coherus said the FDA didn't identify any issues with the drug itself and didn't request any additional data or trials.
Udenyca, a biosimilar of Amgen's cancer drug Neulasta, is currently approved by the FDA in a single-dose, prefilled autoinjector presentation.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 25, 2023 09:09 ET (13:09 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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