Medication Competition Act

The Medication Competition Act mandates that the Secretary of Health and Human Services determine and publicly list the exclusivity periods for all licensed biological products. This includes both interchangeable biological products and reference products , aiming to enhance transparency regarding their market protection. For products licensed on or after the act's enactment, the Secretary must list applicable exclusivity periods within 30 days of knowing the expiration date for interchangeable products or within 30 days of licensure for reference products. For products licensed before the act, specific deadlines are set for listing these periods, either 30 days after enactment or within two years, depending on the product type. This measure seeks to provide clear information on when biosimilar and interchangeable products can enter the market, fostering increased competition.