How Coherus Overcame FDA’s Doubts About Udenyca Immunogenicity
Executive Summary
Better immunogenicity assays overcame concerns raised in complete response letter for Udenyca, leading to approval of the Neulasta biosimilar.
You may also be interested in...
Mylan’s Fulphila: First Neulasta Biosimilar’s Road To US Market Slowed Only By Product Quality, GMP Deficiencies
Mylan demonstrated analytical similarity, including for the PEG moiety, and the absence of clinically meaningful differences between MYL-1401H and Amgen’s pegfilgrastim during first review cycle, but it had to resubmit the application after FDA flagged concerns about the biosimilar’s manufacturing process and ongoing facility deficiencies.
Keeping Track: FDA Starts November With A Bang
The latest drug development news and highlights from our FDA Performance Tracker.
Neulasta Biosimilar From Coherus Needs Better Immunogenicity Assay After Stumble At US FDA
Despite facing one-year delay, Coherus is buoyed by FDA’s apparent support for its decision not to conduct clinical study in cancer patients; agency requests company develop more sensitive immunogenicity assay and reanalyze subset of samples from study conducted in healthy subjects.