Can Biosimilar Studies Be Conducted Solely In Healthy Volunteers?
Executive Summary
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.
You may also be interested in...
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.
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.
Apotex Moves To Block Coherus' Neulasta Biosimilar; Asks FDA To Require Patient Studies
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.