S1096Reported by Committee

Preserve Access to Affordable Generics and Biosimilars Act

Share:
Introduced
In Committee
3
Passed One Chamber
4
Passed Both
5
Signed into Law
119th
Congress
2025-03-24
Introduced
8
Cosponsors
S
ⓘ
Type

Sponsor

Amy Klobuchar
Amy Klobuchar
Democrat · MN · Senator
Votes with party: 81.4% (877 recorded votes)

Full profile: /officials/K000367

Source: Congress.gov · FEC

Cosponsors (8)

Members who have signed on to support this bill since introduction. Source: Congress.gov.

8 cosponsors on record at Congress.gov. The named list is syncing into Govwatch and will appear here shortly — view on Congress.gov in the meantime.

Latest Action

The most recent step in the bill's legislative path. Committee Activity below shows referrals and reports; the full action-by-action history including floor proceedings lives at Congress.gov →

Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.

2025-04-10

Source: Congress.gov

Committee Activity

Currently in

Previously

Plain-English Summary

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.

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

Subjects

Health
Full bill text is not yet cached locally.
Open text viewRead on Congress.gov

Related legislation

Bills by the same sponsor or covering overlapping subjects.