Deems biosimilar biological products interchangeable with their reference products, replacing the separate interchangeability showing with automatic treatment under the Public Health Service Act, subject to timing rules for existing exclusivity periods.

Official title: Biosimilar Red Tape Elimination Act

Next stop Senate floor: awaiting a vote

Timeline each lane is a chamber; dates pull from congress.gov actions

Senate

Introduced 04-JUN-2025

Referred 04-JUN-2025

Approved by committee 17-JUN-2026

Reported 27-JUL-2026

On the calendar 27-JUL-2026

Key points

Deems each biological product licensed as a biosimilar under section 351(k) of the Public Health Service Act interchangeable with its reference product, subject to exclusivity timing rules.
Sets a transition date 60 days after enactment, with products licensed before that date treated as interchangeable on that date.
Keeps any unexpired first interchangeability exclusivity period in effect for its remaining duration.
Makes conforming changes to the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, including pediatric study rules for biosimilars in section 505B, and allows the Secretary of Health and Human Services to issue or revise guidance on biosimilarity data.

AI-generated from the Reported to Senate text of 27-JUL-2026 · verify · report an error

Official CRS summary

Covers an older version. The newest CRS summary describes the bill as of "Introduced in Senate" (04-JUN-2025); the text has changed since (Reported to Senate, 27-JUL-2026).

CRS is the Library of Congress's nonpartisan research office. Read it on congress.gov

Committee referrals (1)

Health, Education, Labor, and Pensions Committee (Senate)

Policy area

Health

Sponsor Mike Lee (R-UT) Cosponsors · 5

■ 3 D■ 2 R

3 Democrats

2 Republicans

congress.gov page Reported to Senate (27-JUL-2026) Introduced in Senate (04-JUN-2025)