Medication Competition Act

Publish biologic drug exclusivity dates

If enacted, this bill would require the Secretary of Health and Human Services to publish when certain biologic drug exclusivity periods end. It would cover first-interchangeable product exclusivity (paragraph (6)) and reference-product exclusivity (paragraph (7)). For reference products licensed on or after enactment, the Secretary would publish the exclusivity end date within 30 days of licensure. For reference products licensed before enactment, the Secretary would publish those end dates within 2 years after enactment. For first-interchangeable products licensed on or after enactment, the Secretary would publish any paragraph (6) exclusivity not later than 30 days after the earliest date the expiration can be known. For first-interchangeable products licensed before enactment, the Secretary would publish any paragraph (6) exclusivity within 30 days after the later of enactment or the earliest date the expiration can be known. This would make it clearer when biosimilar competition can begin and could help patients, pharmacies, and health plans plan for lower-cost alternatives.