S. 1269: INSULIN Act of 2023

Additionally, the bill modifies the Food and Drug Administration's (FDA) procedures for determining whether a petition to delay the approval of a generic drug was made with the primary purpose of delaying the application and provides for the referral of such petitions to the Federal Trade Commission. The bill also authorizes the FDA to expedite the development and review of applications for products designated as a competitive biosimilar therapy.

Finally, the bill permits prescription drug plan sponsors under Medicare Part D to make certain mid-year changes to the cost-sharing tier of a reference biological product if the sponsor also adds the respective biosimilar product to the same or a lower cost-sharing tier as the reference biological product immediately prior to the change.