Thirty-seven organizations representing manufacturers, health plans and insurers, pharmacy benefit managers, corporate employers, consumers, and patients have banded together to support and hopefully reinvigorate action to pass the bicameral Biosimilar Red Tape Elimination Act.
The Biosimilar Red Tape Elimination Act has been long-awaited, but it is not making much progress through Congress. As of January 22, the House version (HR 5526) has four co-sponsors since its introduction in September 2025. The related legislation in the Senate (S 1954) was introduced in early June last year, sat in Committee since that time, and similarly has gained only four co-sponsors.
In October 2025, FDA Commissioner Marty Makary, MD, stated that a draft guidance was being written to address the same objective—redefine interchangeability for biosimilars so that any approved biosimilar is deemed interchangeable. As of January 22, the bills are stuck in committee, and the FDA has not issued the anticipated draft guidance.
No Clinically Meaningful Difference Between Biosimilar and Interchangeable Biosimilars
The Association for Accessible Medicines announced the joint letter, which was sent to the chairmen and ranking members of the House and Senate committees, where the bills currently reside, asking them to “advance this crucial legislation.”
“There is no clinically meaningful difference between biosimilar and interchangeable biosimilar medicines,” said John Murphy III, President and CEO of AAM. “Interchangeability is a designation created by legislative language instead of science, doesn’t exist in any other country. We are thankful to the bill sponsors in the House and the Senate as well as the many groups who have joined us.”
“Unfortunately, the statutory distinction between biosimilars and interchangeable biosimilars continues to generate confusion and misinformation about the safety of biosimilar medicines,” states the letter. “The [FDA] has consistently affirmed that there is no scientific difference between biosimilars and interchangeable biologics.”
