S 1096 119th Congress
Preserve Access to Affordable Generics and Biosimilars Act
A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products.
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Bill journey
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Introduction Congress.gov
Introduced
Introduced in the Senate.
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Read twice and referred to the Committee on the Judiciary.
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Introduced in Senate
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Introduced in Senate
A dated text-version record is available.
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Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
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Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.
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Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
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Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
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Reported to Senate
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View the complete bill journey as an accessible table
| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the Senate. | Congress.gov | |
| Official actionRead twice and referred to the Committee on the Judiciary. | No additional detail supplied.IntroReferral · Senate | Congress.gov | |
| Official actionIntroduced in Senate | No additional detail supplied.IntroReferral · Library of Congress · Code 10000 | Congress.gov | |
| Text versionIntroduced in Senate | A dated text-version record is available. | Congress.gov | |
| Official actionCommittee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionPlaced on Senate Legislative Calendar under General Orders. Calendar No. 46. | No additional detail supplied.Calendars · Senate | Congress.gov | |
| Official actionCommittee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionCommittee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report. | No additional detail supplied.Committee · Library of Congress · Code 14000 | Congress.gov | |
| Text versionReported to Senate | A dated text-version record is available. | Congress.gov |
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Congressional Research Service
CRS summary
Preserve Access to Affordable Generics and Biosimilars ActThis bill prohibits parties from entering into any agreement that resolves or settles a patent claim related to the sale of a drug or biological product and that has anticompetitive effects. Such an agreement is presumed to have anticompetitive effects if the filer of a generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.An agreement is exempt if the only consideration granted to the generic manufacturer is (1) the right to market and secure final approval for its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a U.S. patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.The bill provides for enforcement by the Federal Trade Commission (FTC). Violators are subject to penalties including the forfeiture of the 180-day marketing exclusivity period for a generic drug.Additionally, when a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC and the Department of Justice concerning the agreement contains the complete agreement and any related agreements, including descriptions of any oral agreements or representations.
Official documents
Text versions
- Reported to SenateApr 10, 2025
- Introduced in SenateMar 24, 2025