FTC Comment On FDA Draft Guidance On Interchangeability

We recently posted on a new FDA draft guidance entitled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers," aimed at providing "answers to commonly asked questions from applicants and other interested parties . . . regarding postapproval manufacturing changes . . . made to licensed biosimilars and licensed interchangeable biosimilars."

Last week, the FTC published a comment supporting the FDA's draft guidance, stating an interest in the draft guidance because "[c]ompetition brings substantial benefits to consumers through lower prices, greater access to higher quality goods and services, and increased innovation." The FTC highlighted that the draft guidance no longer recommends clinical switching studies for applications seeking an interchangeable designation, commenting that clinical switching studies can be "time-consuming and expensive" and that "relying on clinical switching studies to establish