S. 4332 — Medication Competition Act

This section requires the Secretary of Health and Human Services to determine applicable exclusivity periods under Public Health Service Act §351(k)(6) (first interchangeable biological product exclusivity, during which no other interchangeable product referencing the same reference product may be licensed) or §351(k)(7) (12-year reference product exclusivity, during which no biosimilar product may be licensed), and to publish those expiration dates on the list under §351(k)(9)(A)(iv), as follows: (1) for first interchangeable products licensed on or after enactment of the Medication Competition Act, not later than 30 days after the earliest date the expiration date can be known; for those licensed before enactment, not later than 30 days after the later of enactment or that earliest date; (2) for reference products licensed on or after enactment, not later than 30 days after licensure; and for those licensed before enactment, not later than two years after enactment. (Thus, the amendment establishes firm deadlines for listing exclusivity to facilitate biosimilar and interchangeable product development and market entry.)