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S. 1096: Preserve Access to Affordable Generics and Biosimilars Act

119th Congress · introduced 2025-03-24 · Health · Latest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.

federal

What does this mean?

Official title

Preserve Access to Affordable Generics and Biosimilars Act

Plain 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.

Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.

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If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Preserve Access to Affordable Generics and Biosimilars Act

Source: Congressional Research Service summary (Introduced in Senate)

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Officials and money

Sponsor: Sen. Klobuchar, Amy [D-MN] · 8 cosponsors

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Words on this page, explained (3)
Bill
A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).
Exemption
A rule that removes certain people, property or activities from a tax or requirement.
Statute
A written law passed by a legislature. A statute can be changed by a later law; changing a constitution needs an amendment.

Plain meanings written from linked sources. All words.

Sources

Record fed-us-cong119-s1096 · catalog fed-us-congress-bills-cong119 · updated 2026-11-03 by psicol fed-bills