Expedited Access to Biosimilars Act

Hozzl · 2026-07-31T13:22:18Z

Explore the details of House Bill 9661 Expedited Access to Biosimilars Act currently in Congress. Get insights into its purpose, current status, sponsors, and potential impact on Health. Stay informed on legislative developments.

7/31/2026, 1:22 PM

Summary of Bill HR 9661

H.R. 9661 in the 119th Congress, introduced on July 14, 2026, aims to amend the Public Health Service Act regarding the licensure of biological products as biosimilar. The bill seeks to establish that the default expectation for licensure does not involve clinical studies assessing pharmacodynamics or comparative clinical efficacy.

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Current Status of Bill HR 9661

Bill HR 9661 is currently in the status of Bill Introduced since July 14, 2026. Bill HR 9661 was introduced during Congress 119 and was introduced to the House on July 14, 2026. Bill HR 9661's most recent activity was Referred to the House Committee on Energy and Commerce. as of July 14, 2026

Bipartisan Support of Bill HR 9661

Total Number of Sponsors

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Unaffiliated Sponsors

Total Number of Cosponsors

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Policy Area and Potential Impact of Bill HR 9661

Primary Policy Focus

Health

Alternate Title(s) of Bill HR 9661

To amend the Public Health Service Act to codify that the default expectation for licensure of biological products as biosimilar does not include clinical studies assessing pharmacodynamics or comparative clinical efficacy, and for other purposes.