Docket Room
HR 9661·Federal·house

Expedited Access to Biosimilars Act

In Committee
Sponsor: Rep. Langworthy, Nicholas A. [R-NY-23] (R)
Latest Action

Referred to the House Committee on Energy and Commerce.

Jul 14, 2026

Summary

The bill changes the Public Health Service Act so that, by default, companies seeking approval for biosimilar biological products will not have to conduct clinical studies on pharmacodynamics or comparative clinical efficacy. This affects drug manufacturers, the FDA, and patients who may see faster, lower‑cost access to biosimilars. The goal is to reduce development burdens while maintaining safety standards.

AI-generated summary — may be incomplete or inaccurate. Verify against the official bill text.

Share

Track this bill

Get real-time alerts when HR 9661 changes status, plus AI-powered summaries and stage predictions.

Sign up free
Docket Room · Nonpartisan legislative tracking
Docket Room IntelligencePro

Ask about your legislation

I can analyze your tracked bills, upcoming hearings, and recent changes.

AI-generated · Nonpartisan · Not legal advice