Biosimilars Access and Affordability Act

This bill changes when biosimilar biological products become eligible for Medicare price negotiations under the Social Security Act. It amends rules for delaying the selection of a reference biological product for negotiation if a biosimilar version is expected to be marketed soon.

Sec. 2, Change of when biosimilars are eligible for price negotiations: The bill modifies Section 1192 of the Social Security Act. It changes the timing for when a drug is no longer considered a selected drug for negotiation. It adds an automatic delay in selecting a reference biological product if the biosimilar manufacturer publicly discloses that its application was accepted or approved by the FDA, a clinical study was initiated and is ongoing, or it expects the biosimilar to be marketed within 2 years after the selected drug publication date. It also allows a delay upon request if the Secretary finds clear and convincing evidence the biosimilar will be marketed within the specified time. If the biosimilar is not licensed and marketed during the delay, the reference product is added to the negotiation list for a later year, and the manufacturer must pay a rebate. The rebate amount is 75% (for Part D) or 80% (for Part B) of the excess of the average manufacturer price or payment amount over the maximum fair price, with adjustments for the second year of delay. The bill defines 'market' as introducing a drug into interstate commerce. Conforming amendments update cross-references. The changes apply to initial price applicability years starting with 2027.