US tracker

S. 1414

Expedited Access to Biosimilars Act

Health, Education, Labor, and Pensions Committee · Sen. Rand Paul (R-KY)

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 remove requirements for certain clinical studies on immunogenicity, pharmacodynamics, and comparative clinical effectiveness when manufacturers seek approval for biosimilar drugs—cheaper alternatives to existing biologic medications. This change aims to streamline and expedite the approval process for these follow-on biological products.

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Posted 10 September 2026

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

S. 1414 | Expedited Access to Biosimilars Act | Sen. Rand Paul (R-KY) | 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 remove requirements for certain clinical studies on immunogenicity, pharmacodynamics, and comparative clinical effectiveness when manufacturers seek approval for biosimilar drugs—cheaper alternatives to existing biologic medications. This change aims to streamline and expedite the approval process for these follow-on biological products. [AI-Generated]

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