US tracker

S. 1954

Biosimilar Red Tape Elimination Act

Health, Education, Labor, and Pensions Committee · Sen. Mike Lee (R-UT)

27 July 2026 | Reported by committee (Health, Education, Labor, and Pensions, with an amendment in the nature of a substitute, without written report)

What's next: Floor scheduling (leadership decides if and when it gets a vote)

Summary: The bill would automatically deem all biosimilars approved by the FDA to be interchangeable with their original brand-name biological products, eliminating additional testing requirements currently needed to earn that designation. This would allow pharmacists to substitute biosimilars for brand-name drugs more easily, though it would preserve the exclusive marketing period for the first biosimilar approved for each reference product.

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Posted 10 September 2026

As published — the exact text this tracker posted, kept verbatim for the record

S. 1954 | Biosimilar Red Tape Elimination Act | Sen. Mike Lee (R-UT) | Health, Education, Labor, and Pensions Committee 📅 27 July 2026 | 📋 Reported by committee (Health, Education, Labor, and Pensions, with an amendment in the nature of a substitute, without written report) What's next: Floor scheduling (leadership decides if and when it gets a vote) Summary: The bill would automatically deem all biosimilars approved by the FDA to be interchangeable with their original brand-name biological products, eliminating additional testing requirements currently needed to earn that designation. This would allow pharmacists to substitute biosimilars for brand-name drugs more easily, though it would preserve the exclusive marketing period for the first biosimilar approved for each reference product. [AI-Generated]

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