FDA Sets Hierarchy for Biosimilars Evidence

Überblick


Paul Radensky said that the FDA’s step-by-step approach in new guidelines for pharmaceutical companies to submit evidence of biosimilarity is “to be expected” because it mirrors the data needed for approval of generics. “It’s the natural hierarchy you would think about in terms of the information you would have to help characterize one product versus another,” Mr. Radensky explained, adding that the guidance steps “show maturation in thinking about the process they are going to use and the criteria and how they will organize the answers people are going to get back.”