Bill · S. 5571· Senate(119-S-5571)
Biosimilars Access and Affordability Act
- Introduced
- 9/28/2026
- Last activity
- 9/28/2026 — Read twice and referred to the Committee on Finance.
- Sponsored by
- Marsha Blackburn
- Cosponsors
- - 2 - 1
- Introduced
- In Committee
What this bill would do
This bill is called the "Biosimilars Access and Affordability Act" and it changes when biosimilar biological products are eligible for price negotiations under the Medicare program. It amends title XI of the Social Security Act to alter these rules. Specifically, it adjusts the timing of when biological products are eligible for price negotiations. The bill also establishes rules for automatic delays and sets requirements for manufacturers. Finally, it outlines the payment of rebates if certain conditions are not met.
Yes· 3 of 7
Would people over 65 be better off under this?+3
Seniors relying on Medicare will benefit from enhanced access and affordability regarding biological products and biosimilars.
Would retired people be better off under this?+3
Retirees on Medicare benefit from provisions aimed at improving the availability and affordability of biological products.
Does this lower the price of prescription medicines?+3
By facilitating the entry of biosimilars and adjusting negotiation timelines, the bill aims to improve prescription drug availability and affordability.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
- Automatic delay for biosimilars: Under section 2(a)(2)(A), the Secretary shall apply an automatic delay for a biological product if the manufacturer of a biosimilar biological product has publicly disclosed that their application was accepted for review or approved by the Food and Drug Administration, or that clinical studies were initiated and remain ongoing, are complete, or that no studies are necessary, and expects the product to be marketed before the date that is 2 years after the selected drug publication date. This helps encourage the entry of biosimilars into the market.
Potential Negative Impacts for People
- Rebate requirements for manufacturers: Under section 2(a)(2)(B)(ii), if a biosimilar biological product has not been licensed and marketed on or before the date that is 2 years after the selected drug publication date, the manufacturer of the reference biological product shall pay a rebate. This could potentially create financial burdens or disputes for manufacturers involved in the process.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Retirees+3Good For Seniors+3Good For Low Income Households+2Good For Middle Class Households+2
- Healthcare
- Reduces Prescription Drug Costs+3Improves Healthcare Access+2Increases Medicare Funding+2
- 9/28/2026
- Read twice and referred to the Committee on Finance.
- 3 Cosponsors added.
- Introduced in Senate
Ted BuddRepublican · North Carolina
James LankfordRepublican · Oklahoma
Adam SchiffDemocrat · California