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# Bill Introduced on Biosimilar Substitutions
- URL: https://www.fdaweb.com/bill-introduced-on-biosimilar-substitutions/
- Published: 2023-07-14T12:00:00.000Z
- Updated: 2026-09-14T18:44:17.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154880

Senators **Mike Lee** (R-UT), **Ben Ray Luján** (D-NM), **Mike Braun** (R-IN), and **J.D. Vance** (R-OH) have introduced the Biosimilar Red Tape Elimination Act to increase competition within the biosimilar drug market and increase access to low-cost drugs. The legislation would deem approved biosimilars as interchangeable with their branded equivalent. For the most part, it would allow interchangeability without having to perform switching studies, but in certain circumstances, the studies could be required. “Eliminating the barrier of interchangeability would increase access to lower-cost biosimilars and save payers and consumers billions over the next five years,” the lawmakers said.

According to a [summary](https://www.lee.senate.gov/services/files/425FA883-85E2-46B1-980E-32913482BFF6?ref=fdaweb.com) of the measure, FDA would be required to conduct a private briefing with relevant committee heads if the agency wants to require a switching study. It also would not affect states’ ability to implement their own laws on biosimilar substitution. “It would merely send an accurate signal to the states regarding the nature of interchangeability,” it says.