Preserve Access to Affordable Generics and Biosimilars Act
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 bio… Show full official titleShow less
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.
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Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.
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.
- Introduced in Senate Formatted Text PDF Formatted XML
- Reported to Senate Formatted Text PDF Formatted XML
- BCBSM, INC.
- PUBLIC CITIZEN
- BIOTECHNOLOGY INNOVATION ORGANIZATION
- TWINLOGIC STRATEGIES, LLP
- BLUE CROSS AND BLUE SHIELD OF KANSAS, INC.
- AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)
Bodies those filers lobbied
- SENATE
- HOUSE OF REPRESENTATIVES
- Centers For Medicare and Medicaid Services (CMS)
- Health & Human Services, Dept of (HHS)
- White House Office
- Office of Management & Budget (OMB)
- Executive Office of the President (EOP)
- Patent & Trademark Office (PTO)
Cite this page
U.S. Congress. (2026). S. 1096: Preserve Access to Affordable Generics and Biosimilars Act. 119th Congress. Open America. https://openamerica.io/bill/119-S-1096/
"S. 1096: Preserve Access to Affordable Generics and Biosimilars Act." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-S-1096/.
S. 1096, 119th Cong. (2026), https://openamerica.io/bill/119-S-1096/.
[S. 1096: Preserve Access to Affordable Generics and Biosimilars Act](https://openamerica.io/bill/119-S-1096/)