Preserve Access to Affordable Generics and Biosimilars Act

Hozzl · 2025-04-15T04:23:16Z

Explore the details of Senate Bill 1096 Preserve Access to Affordable Generics and Biosimilars Act currently in Congress. Get insights into its purpose, current status, sponsors, and potential impact on Health. Stay informed on legislative developments.

4/15/2025, 4:23 AM

Summary of Bill S 1096

Bill 119 s 1096, also known as the "Preserve Access to Affordable Generics and Biosimilars Act," aims to address the issue of brand name drug companies paying generic drug companies to delay the entry of generic drugs into the market. This practice, known as "pay-for-delay," can result in higher drug prices for consumers and limit competition in the pharmaceutical industry.

The bill specifically prohibits brand name drug companies from compensating generic drug companies to delay the entry of generic drugs into the market. Additionally, it also prohibits biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products.

By preventing these types of agreements, the bill seeks to promote competition in the pharmaceutical industry and increase access to affordable generic and biosimilar drugs for consumers. This legislation is important in ensuring that patients have access to more affordable medication options and that the market remains competitive. Overall, Bill 119 s 1096 aims to protect consumers from potentially harmful practices that can drive up drug prices and limit access to affordable medications. It is a step towards promoting a more competitive and transparent pharmaceutical industry.

Congressional Summary of S 1096

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.

Read the Full Bill

Formatted Text PDF Formatted XML

Current Status of Bill S 1096

Bill S 1096 is currently in the status of Bill Introduced since March 24, 2025. Bill S 1096 was introduced during Congress 119 and was introduced to the Senate on March 24, 2025. Bill S 1096's most recent activity was Placed on Senate Legislative Calendar under General Orders. Calendar No. 46. as of April 10, 2025

Bipartisan Support of Bill S 1096

Total Number of Sponsors

Democrat Sponsors

Republican Sponsors

Unaffiliated Sponsors

Total Number of Cosponsors

Democrat Cosponsors

Republican Cosponsors

Unaffiliated Cosponsors

Policy Area and Potential Impact of Bill S 1096

Primary Policy Focus

Health

Alternate Title(s) of Bill S 1096

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.