James C. Shehan, Chair of Lowenstein’s FDA Regulatory practice, is interviewed on the “Not So Different” podcast by the Center for Biosimilars on the FDA’s recently released final guidelines on demonstrating interchangeability, which Shehan knows well because he helped craft the sections of the Biologics Price Competition and Innovation Act that govern interchangeability. He also addresses the upcoming transition of insulin to its regulation as a biologic instead of as a drug, and the possibility of it being categorized as an interchangeable one day.