S. 1096 · 119th Congress

Preserve Access to Affordable Generics and Biosimilars Act

Introduced on Mar 24, 2025 by Amy Klobuchar (D-MN). 8 cosponsors, 3 of them from another party. Latest action (Apr 10, 2025): Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.

Stage
Reported by committee
Introduced
Mar 24, 2025
Cosponsors
8
3 from the other party
Policy area
Health
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Progress

The furthest stage the measure reached. Simple and concurrent resolutions do not go to the President.

  1. Introduced
  2. Reported by committee
  3. 3Passed one chamber
  4. 4Passed both chambers
  5. 5Sent to the President
  6. 6Became law

Official title

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.

Subjects

  • Administrative law and regulatory procedures
  • Civil actions and liability
  • Competition and antitrust
  • Contracts and agency
  • Federal Trade Commission (FTC)
  • Intellectual property
  • Judicial review and appeals
  • Licensing and registrations
  • Manufacturing
  • Marketing and advertising
  • Prescription drugs

Summary

By the Congressional Research Service (Introduced in Senate, Mar 24, 2025). Public domain.

Preserve Access to Affordable Generics and Biosimilars Act

This 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.

Sponsor and cosponsors

Cosponsors by party as of the day they signed on. Original cosponsors signed on the day of introduction.

Amy KlobucharD-MNSponsor

Democrats · 5

Republicans · 3

Roll calls

Recorded votes on the measure. Most measures move by voice vote or unanimous consent, which record no individual positions.

No recorded roll call on this measure: it moved by voice vote or unanimous consent, or has not reached the floor.

History

Every action as published, oldest first. Roll calls link to how each member voted.

  1. Mar 24, 2025Introduced in Senate
  2. Mar 24, 2025 · SenateRead twice and referred to the Committee on the Judiciary.
  3. Apr 3, 2025 · SenateCommittee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
  4. Apr 10, 2025Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
  5. Apr 10, 2025 · SenateCommittee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.
  6. Apr 10, 2025 · SenatePlaced on Senate Legislative Calendar under General Orders. Calendar No. 46.

Committees

Committees and subcommittees the measure was referred to.

Agencies in its committees' jurisdiction

Analisa's mapping of committee jurisdiction to federal agencies; the bill may touch others, or none of these.

Who lobbied on it

Organizations whose lobbying reports (LD-2) name this measure. Spending is what they reported for those quarters on all issues, not on this measure alone.

  1. ASSOCIATION FOR ACCESSIBLE MEDICINES15 reports
    $4.9M reported (all issues)
  2. PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA15 reports
    $57.5M reported (all issues)
  3. AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)6 reports
    $25.6M reported (all issues)
  4. AMERICAN INTELLECTUAL PROPERTY LAW ASSOCIATION (AIPLA)6 reports
    $60K reported (all issues)
  5. BCBSM, Inc.6 reports
    $176K reported (all issues)
  6. BLUE CROSS BLUE SHIELD OF MICHIGAN6 reports
    $1.6M reported (all issues)
  7. Blue Cross and Blue Shield Association6 reports
    $7.5M reported (all issues)
  8. Blue Cross and Blue Shield of Florida, Inc.6 reports
    $710K reported (all issues)
  9. CAMBIA HEALTH SOLUTIONS INC.6 reports
    $3.9M reported (all issues)
  10. Campaign for Sustainable Drug Pricing (CSRxP)6 reports
    $300K reported (all issues)
  11. GSK (fka GLAXOSMITHKLINE INC.)6 reports
    $7.4M reported (all issues)
  12. GUIDEWELL MUTUAL HOLDING CORPORATION6 reports
    $40K reported (all issues)
  13. NOVARTIS CORPORATION6 reports
    $13.1M reported (all issues)Federal contractor: NOVARTIS PHARMACEUTICALS CORPORATION$36.2M in contracts, FY2026AI match · 100%
  14. TEVA PHARMACEUTICALS USA, INC.6 reports
    Federal contractor: TEVA PHARMACEUTICALS USA, INC.$25.9M in contracts, FY2026AI match · 100%
  15. The Campaign for Sustainable Rx Pricing6 reports
    $540K reported (all issues)
  16. BIOTECHNOLOGY INNOVATION ORGANIZATION5 reports
    $7.7M reported (all issues)
  17. BLUE CROSS AND BLUE SHIELD OF KANSAS, INC.5 reports
    $50K reported (all issues)
  18. ELI LILLY AND COMPANY5 reports
    Federal contractor: ELI LILLY AND COMPANY$286.4K in contracts, FY2026AI match · 100%
  19. Viatris (Mylan, Inc)5 reports
    $300K reported (all issues)
  20. Families USA Foundation, Inc.4 reports
    $38K reported (all issues)
  21. T1INTERNATIONAL USA4 reports
  22. AARP3 reports
    $15.6M reported (all issues)
  23. KAISER FOUNDATION HEALTH PLAN INC.3 reports
    $1.6M reported (all issues)Federal contractor: KAISER FOUNDATION HEALTH PLAN OF WASHINGTONAI match · 97%
  24. BLUECROSS BLUESHIELD OF TENNESSEE2 reports
    $360K reported (all issues)
  25. Chamber of Commerce of the U.S.A.2 reports
    $33M reported (all issues)
  26. PHARMACEUTICAL CARE MANAGEMENT ASSOCIATION2 reports
    $6.3M reported (all issues)
  27. Public Citizen2 reports
    $172.6K reported (all issues)
  28. SMALL BUSINESS & ENTREPRENEURSHIP COUNCIL (SBE COUNCIL)2 reports
    $105K reported (all issues)
  29. ABBVIE1 report
    $2.1M reported (all issues)Federal contractor: ABBVIE US LLC$154.6K in contracts, FY2026AI match · 100%
  30. Association of Accessible Medicines (formerly known as GPhA)1 report
    $60K reported (all issues)
  31. Blood Cancer United (FKA The Leukemia & Lymphoma Society)1 report
    $590K reported (all issues)
  32. Cambia Health Solutions (formerly known as The Regence Group)1 report
    $80K reported (all issues)
  33. Fresenius Kabi USA LLC1 report
    $340K reported (all issues)Federal contractor: FRESENIUS KABI USA, LLCAI match · 100%
  34. GENENTECH INC.1 report
    Federal contractor: GENENTECH USA, INC$939.6K in contracts, FY2026AI match · 100%
  35. Stanford University1 report
    $180K reported (all issues)

Reports filed in 2025, 2026.

Sources and method

Every figure on this page traces to these records.

  • Bill status: bills and resolutions, sponsors, actions, subjects and CRS summaries (U.S. Government Publishing Office (GovInfo), from Congress.gov (Library of Congress))GovInfo Bill Status bulk data (Congress.gov; summaries by the Congressional Research Service) · data current to Oct 10, 2026 · loaded Oct 10, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Members of Congress, their terms, committees and identifiers (The @unitedstates project (from the Biographical Directory of the U.S. Congress, the House and the Senate))unitedstates/congress-legislators: legislators, committees and current committee membership · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: CC0 1.0 (public domain dedication)
  • House roll-call votes (Office of the Clerk, U.S. House of Representatives)Office of the Clerk, U.S. House of Representatives, roll-call vote records · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Senate roll-call votes and DW-NOMINATE scores (Voteview (UCLA Department of Political Science))Lewis, Jeffrey B., Keith Poole, Howard Rosenthal, Adam Boche, Aaron Rudkin, and Luke Sonnet (2026). Voteview: Congressional Roll-Call Votes Database. https://voteview.com/ · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Free to use with the required citation
  • Lobbying disclosures (LD-1 registrations, LD-2 quarterly reports, LD-203 contribution reports) (Clerk of the U.S. House of Representatives)Clerk of the House, Lobbying Disclosure Act filings (organizations only; lobbyists' names are not loaded) · data current to Oct 10, 2026 · loaded Oct 10, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Positions are shown only where a roll call recorded them; voice votes and unanimous consent record none.
  • Money and votes are shown side by side; neither explains the other.