S 1096 United States Senate · 119th Congress

Preserve Access to Affordable Generics and Biosimilars Act

This bill prohibits "reverse payment" agreements where brand-name drug companies pay generic or biosimilar manufacturers to delay entering the market, which harms competition. It creates a presumption that such agreements are anticompetitive if a generic or biosimilar company receives value in exchange for delaying market entry, with exceptions for standard settlements involving early market entry rights or reasonable litigation expenses. The bill amends the Federal Trade Commission Act to enforce this new prohibition and requires certification of such agreements, aiming to enhance competition and lower drug costs for consumers. This would directly affect brand-name drug companies, generic manufacturers, and biosimilar biological product manufacturers.
Bill status in committee 1 of 4 stages cleared
Introduction
Mar 2025
Committee Review
Floor Vote
President
Introduced Mar 24, 2025 Last action Apr 10, 2025
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Full legislative history

Actions timeline

Total actions
5
Key actions
2
Committee
3
Apr 10, 2025
Upper · Passed
Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
upper
Apr 3, 2025
Upper · Passed
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
upper
Mar 24, 2025
Committee
Read twice and referred to the Committee on the Judiciary.
upper
Mar 24, 2025
Introduced
Introduced in Senate
upper
1 primary · 8 co-sponsors

Sponsors