ROCKVILLE, Md. — The Food and Drug Administration moved one step closer to establishing a biosimilar pathway with a new guidance document explaining how to use clinical pharmacology data to show similarity to a reference product, according to a report published by Regulatory Focus on Tuesday.
"These studies provide the data that describe the degree of similarity in drug exposure between the proposed biosimilar and the reference product," the FDA noted in its guidance. "In addition, clinical pharmacology studies often include [pharmacodynamic] endpoints (both therapeutic and toxic) and pharmacometric analysis to assess whether or not there are clinically meaningful differences between the proposed biosimilar and the reference product."
According to the report, the latest guidance follows the publication of five other biosimilar draft guidance documents.