Biosimilars Access and Affordability Act

This bill amends the Social Security Act to change when biosimilar biological products become eligible for Medicare price negotiations. It modifies the rules for delaying the selection of a reference biological product for negotiation if a biosimilar is expected to enter the market soon, and it extends the delay period from one year to two years.

Sec. 2, Change of when biosimilars are eligible for price negotiations: The bill revises Section 1192 of the Social Security Act to alter the timing and conditions under which a biological product is selected for Medicare price negotiation. It provides for an automatic two-year delay in selection if the manufacturer of a biosimilar has publicly disclosed that its application was accepted or approved by the FDA, or that clinical studies are ongoing or complete, and the Secretary determines the biosimilar is expected to be marketed within two years after the selected drug publication date. If the biosimilar is not licensed and marketed during the delay, the biological product is added to the negotiation list for the year two years later, and the manufacturer must pay a rebate. The bill also defines "marketed" as introduced or delivered for introduction into interstate commerce. The amendments apply to initial price applicability years beginning with 2026.