# 119-s-1096: Preserve Access to Affordable Generics and Biosimilars Act

119-s-1096, Preserve Access to Affordable Generics and Biosimilars Act, is a 119th Congress bill sponsored by Sen. Klobuchar, Amy [D-MN] (D-MN); status in_committee; PRIA reads it as touching household money (as of 2026-08-11).

- Canonical: https://policyrisk.com/legislation/119-s-1096
- As of: 2026-08-11
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-1096
- Congress: 119
- Title: Preserve Access to Affordable Generics and Biosimilars Act
- Status: in_committee
- Introduced: 2025-03-24
- Sponsor: Sen. Klobuchar, Amy [D-MN] (D-MN)
- Cosponsors: 8
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-08-11

## Summary

**Protects access to lower-cost generic and biosimilar medicines** by targeting settlement deals that delay competitors. The bill would create a new Section 27 in the Federal Trade Commission Act that presumes certain patent settlements are anticompetitive when an ANDA or biosimilar filer gets value and agrees to limit competition. - Families and patients: Could speed entry of generics and biosimilars by deterring pay-for-delay and other deals that postpone competition, which can improve access and pressure prices downward. - Generic and biosimilar applicants: Creates a presumption of anticompetitive effects if they receive value and agree to limit research, manufacturing, marketing, or sales, while allowing rebuttal and a narrow safe harbor for claims of litigation expenses capped at $7.5 million in 2025 and adjusted later. - Brand companies and regulators: Restricts common settlement options, exposes violators to civil penalties up to three times the value attributable to the violation and possible forfeiture of the first applicant's 180-day exclusivity. The FTC gets explicit authority to seek penalties and injunctions and the bill adds chief-officer certification and expanded notification rules for patent-related agreements.

## Cosponsors (8)

- Sen. Grassley, Chuck [R-IA] (R-IA), 2025-03-24T00:00:00.000Z
- Sen. Durbin, Richard J. [D-IL] (D-IL), 2025-03-24T00:00:00.000Z
- Sen. Cramer, Kevin [R-ND] (R-ND), 2025-03-24T00:00:00.000Z
- Sen. Blumenthal, Richard [D-CT] (D-CT), 2025-03-24T00:00:00.000Z
- Sen. Ernst, Joni [R-IA] (R-IA), 2025-03-24T00:00:00.000Z
- Sen. Welch, Peter [D-VT] (D-VT), 2025-03-24T00:00:00.000Z
- Sen. Kelly, Mark [D-AZ] (D-AZ), 2025-03-24T00:00:00.000Z
- Sen. Booker, Cory A. [D-NJ] (D-NJ), 2025-03-24T00:00:00.000Z

## Provisions PRIA read

- Ban on anticompetitive drug deals: benefit, high. This bill would make most patent-settlement deals that keep cheaper generics or biosimilars off the market illegal. It would create a rebuttable presumption that a deal is anticompetitive when a generic or biosimilar applicant gets anything of value and agrees to limit research, making, marketing,…
- Stronger fines and generic exclusivity loss: benefit, high. This bill would let the FTC sue in federal court when it thinks a settlement broke the new rule. Courts could fine violators up to three times the value tied to the unlawful transfer, and judges must weigh harm, culpability, profits, ability to pay, and other factors when setting fines. The FTC mus…
- CEO certification for Medicare drug filings: benefit, medium. This bill would require the CEO or lead negotiator to file a certification within 30 days after filing certain drug-settlement agreements with DOJ and the FTC. The certification would say the filing is complete and list any side deals or oral promises. Filings would also have to notify patent owner…

## Related bills

- 119-s-5066: Health Equity and Accountability Act of 2026
- 119-s-1241: Sanctioning Russia Act of 2025
- 119-sres-913: A resolution relating to the death of the Honorable Nancy Kassebaum, former United States Senator for the State of Kansas.
- 119-sres-897: A resolution honoring the life, service, and legacy of the Honorable Jon Llewellyn Kyl, former Senator for the State of Arizona.
- 119-sres-801: A resolution honoring the life and legacy of the Honorable Lindsey Olin Graham, a Senator from the State of South Carolina.
- 119-sres-755: A resolution honoring the life of the Honorable Donald W. Riegle, Jr., former Senator for the State of Michigan.

## Sources
- [119-s-1096 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/1096)

## Related
- [119-s-5066: Health Equity and Accountability Act of 2026](https://policyrisk.com/legislation/119-s-5066)
- [119-s-1241: Sanctioning Russia Act of 2025](https://policyrisk.com/legislation/119-s-1241)
- [119-sres-913: A resolution relating to the death of the Honorable Nancy Kassebaum, former Uni…](https://policyrisk.com/legislation/119-sres-913)
- [119-sres-897: A resolution honoring the life, service, and legacy of the Honorable Jon Llewel…](https://policyrisk.com/legislation/119-sres-897)
- [119-sres-801: A resolution honoring the life and legacy of the Honorable Lindsey Olin Graham,…](https://policyrisk.com/legislation/119-sres-801)
- [119-sres-755: A resolution honoring the life of the Honorable Donald W. Riegle, Jr., former S…](https://policyrisk.com/legislation/119-sres-755)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-1096 (as of 2026-08-11).