Insulin Patents and Market Exclusivities: Unresolved Issues (Reply)

Responding to commentary on the global implications of U.S. insulin patent landscapes, the authors outline two regulatory pathways for follow-on insulin approval—the 505(b)(2) pathway and the Biologics Price Competition and Innovation Act—and warn that after 2020, regulatory transitions could create a problematic gap in which no follow-on insulin application could be approved. They argue that the key factor for affordability will be whether follow-on insulins achieve interchangeability status, and caution that biosimilar insulins alone, without additional policy interventions, are unlikely to produce meaningful near-term cost reductions for patients.