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.
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Coherus refutes Apotex argument that Neulasta biosimilars must be studied in at least one patient population. Its application could face delay as no advisory committee meeting has been scheduled ahead of its June 9 user fee date.
Apotex argues that biosimilar studies in healthy volunteers are not sufficient to show clinically meaningful differences with the reference product; Coherus says it believes its application is scientifically sound.
Infliximab-abda gains FDA licensure without having faced an advisory committee review; under current case law, launch could come as early as mid-October.