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# Advocacy Groups Press Congress on Biosimilar Legislation
- URL: https://www.fdaweb.com/advocacy-groups-press-congress-on-biosimilar-legislation/
- Published: 2026-01-23T12:00:00.000Z
- Updated: 2026-09-14T15:31:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160536

A broad coalition of healthcare, patient, consumer, and policy organizations is urging Congress to advance legislation that would eliminate the statutory distinction between biosimilars and so-called interchangeable biosimilars, arguing the change would expand patient access and lower healthcare costs.

The Biosimilars Council and the Association for Accessible Medicines (AAM) recently sent a [follow-up letter](https://accessiblemeds.org/wp-content/uploads/2026/01/Group-Support-Letter%5FAdvance-BRTEA%5F012126.pdf?ref=fdaweb.com) to leaders of the Senate and House health committees backing the Biosimilar Red Tape Elimination Act. The letter was signed by more than three dozen advocacy groups covering insurers, employers, patient advocates, and taxpayer organizations.

The bill would remove the legal distinction between biosimilars and interchangeable biosimilars, a designation that advocates say has fueled confusion without providing clinical benefit. “There is no clinically meaningful difference between biosimilar and interchangeable biosimilar medicines,” AAM president **John Murphy III** is quoted in a [release](https://biosimilarscouncil.org/news/over-three-doze-groups-joins-biosimilars-council-aam-support-interchangeability-legislation/?ref=fdaweb.com) as saying. “Interchangeability is a designation created by legislative language instead of science and doesn’t exist in any other country.”

The letter notes that the FDA has repeatedly affirmed that biosimilars and interchangeable biosimilars meet the same standards for safety and effectiveness. FDA commissioner **Marty Makary** has also announced plans to finalize guidance eliminating the requirement for switching studies and has reiterated the agency’s recommendation that Congress remove the distinction.

**Alex Keeton**, executive director of the Biosimilars Council, contends the legislation would “clear up confusion, streamline the approval process, and get critical medicines to patients faster.”