How Coherus Overcame FDA’s Doubts About Udenyca Immunogenicity
Better immunogenicity assays overcame concerns raised in complete response letter for Udenyca, leading to approval of the Neulasta biosimilar.
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The latest drug development news and highlights from our FDA Performance Tracker.
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.