# 116-hr-2375: Preserve Access to Affordable Generics and Biosimilars Act

116-hr-2375, Preserve Access to Affordable Generics and Biosimilars Act, is a 116th Congress bill sponsored by Rep. Nadler, Jerrold [D-NY-12] (D-NY); status Placed on the Union Calendar, Calendar No. 576. (as of 2025-11-18).

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## Facts
- Bill: 116-hr-2375
- Congress: 116
- Title: Preserve Access to Affordable Generics and Biosimilars Act
- Status: Placed on the Union Calendar, Calendar No. 576.
- Introduced: 2019-04-29
- Sponsor: Rep. Nadler, Jerrold [D-NY-12] (D-NY)
- Cosponsors: 4
- Policy area: Health
- Touches household money: no
- Last recorded action: 2025-11-18

## Summary

Preserve Access to Affordable Generics and Biosimilars ActThis bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the 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 exempted if the only consideration granted to the generic manufacturer is (1) the right to market 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 patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects. 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 concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations. The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

## Cosponsors (4)

- Rep. Meadows, Mark [R-NC-11] (R-NC), 2019-05-07T00:00:00.000Z
- Rep. Collins, Doug [R-GA-9] (R-GA), 2019-04-29T00:00:00.000Z
- Rep. Cicilline, David N. [D-RI-1] (D-RI), 2019-04-29T00:00:00.000Z
- Rep. Cohen, Steve [D-TN-9] (D-TN), 2019-04-30T00:00:00.000Z

## Related bills

- 116-hr-2423: Women's Suffrage Centennial Commemorative Coin Act
- 116-hr-748: CARES Act
- 116-hr-6829: EMPIL–DOC Act
- 116-hr-5546: Effective Assistance of Counsel in the Digital Era Act
- 116-hr-4305: PAWS for Veterans Therapy Act
- 116-hr-4104: Negro Leagues Baseball Centennial Commemorative Coin Act

## Sources
- [116-hr-2375 on Congress.gov](https://www.congress.gov/bill/116th-congress/house-bill/2375)

## Related
- [116-hr-2423: Women's Suffrage Centennial Commemorative Coin Act](https://policyrisk.com/legislation/116-hr-2423)
- [116-hr-748: CARES Act](https://policyrisk.com/legislation/116-hr-748)
- [116-hr-6829: EMPIL–DOC Act](https://policyrisk.com/legislation/116-hr-6829)
- [116-hr-5546: Effective Assistance of Counsel in the Digital Era Act](https://policyrisk.com/legislation/116-hr-5546)
- [116-hr-4305: PAWS for Veterans Therapy Act](https://policyrisk.com/legislation/116-hr-4305)
- [116-hr-4104: Negro Leagues Baseball Centennial Commemorative Coin Act](https://policyrisk.com/legislation/116-hr-4104)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/116-hr-2375 (as of 2025-11-18).