Biosimilars Access and Affordability Act

This bill changes when Medicare can pick a brand-name biological drug for price negotiation if a competing biosimilar version is expected soon. It extends the possible delay before such a drug is selected from 1 year to 2 years. It makes the delay automatic in some cases, such as when the biosimilar maker's application or studies are underway and the biosimilar is expected on the market within 2 years. Biosimilar makers would have to confirm key information in writing under penalty of perjury. If the biosimilar does not reach the market in time, the brand-name maker would owe Medicare a rebate. The changes apply starting with the 2026 price year.

Full text and official record on Congress.gov

Sponsors

• Marsha Blackburn Republican sponsor
• 3 cosponsors