FRONT Act

Senate Bill

S. 2305

119th Congress

FRONT Act

In Committee

Introduced:Jul 16, 2025

Primary Sponsor

Jon Ossoff

Senator

Democratic

GA

Cosponsors

4

Quick Stats

Policy Area

Health

Summary

This bill would make it easier for generic versions of expensive biologic drugs, called biosimilars, to be approved and used interchangeably with the original drugs. It removes some of the extra steps and waiting periods that currently slow down the process of getting biosimilars to market.

Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

SponsorJon Ossoff (D-GA)

Introduced7/16/2025

StatusRead twice and referred to the Committee on Foreign Relations.

ChamberSenate

Data from Congress.gov

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Vote Prediction

FRONT Act

This bill would make it easier for generic versions of expensive biologic drugs, called biosimilars, to be approved and used interchangeably with the original drugs. It removes some of the extra steps and waiting periods that currently slow down the process of

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This bill would make it easier for generic versions of expensive biologic drugs, called biosimilars, to be approved and used interchangeably with the original drugs. It removes some of the extra steps and waiting periods that currently slow down the process of getting biosimilars to market.

Bill Number: 2305
Sponsor: Jon Ossoff (D-GA)
Introduced: 7/16/2025
Status: Read twice and referred to the Committee on Foreign Relations.
Policy Area: Health

Data from Congress.gov

AI-generated summary

Fact Sheet

Title: FRONT Act
Bill Number: 2305
Sponsor: Jon Ossoff (D-GA)
Status: Read twice and referred to the Committee on Foreign Relations.
Introduced: 7/16/2025
Summary: This bill would make it easier for generic versions of expensive biologic drugs, called biosimilars, to be approved and used interchangeably with the original drugs. It removes some of the extra steps and waiting periods that currently slow down the process of getting biosimilars to market.

Data from Congress.gov

AI Summary

Plain-English explanation of this bill

This bill would make it easier for generic versions of expensive biologic drugs, called biosimilars, to be approved and used interchangeably with the original drugs. It removes some of the extra steps and waiting periods that currently slow down the process of getting biosimilars to market.

Last updated: 12/30/2025

Official Summary

Congressional Research Service summary

Biosimilar Red Tape Elimination ActThis bill removes certain requirements for biosimilars to be designated as interchangeable. (Biosimilars that are designated as interchangeable may be substituted for the reference product at a pharmacy without a new prescription, depending on state pharmacy laws.)Specifically, the bill establishes a presumption that an approved biosimilar is interchangeable with the reference product without the need for additional evidence from the manufacturer, and it removes the applicable exclusivity periods for a first interchangeable biosimilar (i.e., a product that is the first interchangeable biosimilar to be approved with respect to the reference product).The Food and Drug Administration (FDA) may require a manufacturer of a biosimilar to conduct a safety study with respect to switching or alternating between the biosimilar and the reference product, but only after the FDA briefs certain members of specified congressional committees to explain why the study is necessary.

Key Points

Main provisions of the bill

Establishes a presumption that an approved biosimilar is interchangeable with the original drug, without needing additional evidence from the manufacturer
Removes exclusivity periods for the first interchangeable biosimilar, which currently delay competition
Requires the FDA to brief Congress before requiring a safety study on switching between a biosimilar and the original drug

How This Impacts Americans

Potential effects on citizens and communities

This bill would primarily impact consumers and the healthcare system by making lower-cost biosimilar drugs more widely available sooner. It could lead to significant cost savings for patients and the overall healthcare system, as biosimilar competition tends to drive down prices. Patients, insurers, and government healthcare programs would likely benefit the most from this increased biosimilar access.