Biosimilars Access and Affordability Act

This bill changes when biosimilar biological products are eligible for price negotiations under the Medicare program by amending the Social Security Act. It alters the timing and conditions for delaying the selection of a reference biological product for negotiation if a biosimilar is expected to enter the market.

Sec. 2, Change of when biosimilars are eligible for price negotiations: This section modifies the rules for when a biological product can be delayed from being selected for Medicare price negotiation. It creates an automatic delay if a biosimilar manufacturer 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 2 years after the selected drug publication date. The delay period is extended from 1 year to 2 years. If the biosimilar is not licensed and marketed during the delay, the biological product must be included as a selected drug for the next applicable year, and the manufacturer must pay a rebate of 75% (for Part D) or 80% (for Part B) of the amount by which the average manufacturer price or payment amount exceeds the maximum fair price. The section also defines 'marketed' as introduced or delivered for introduction into interstate commerce.

Effective date: The amendments apply to initial price applicability years beginning with 2027.