H.R. 9661
119th Congress
House
Expedited Access to Biosimilars Act
Official title: To amend the Public Health Service Act to codify that the default expectation for licensure of biological products as biosimilar does not include clinical stud… Show full official titleShow less
Official title: 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.
Everywhere this bill has been
2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 14, 2026
Referred to the House Committee on Energy and Commerce.
Jul 14, 2026
Introduced in House
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What's happening now
Referred to the House Committee on Energy and Commerce.
Hearings & markups
1
Related & companion bills
1
Bill text
1 version
- Introduced in House Formatted Text PDF Formatted XML
Committees of jurisdiction
1
Lobbying activity
13
- AMERICAN SOCIETY OF HEALTH-SYSTEM PHARMACISTS
- AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)
- PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
- GSK (FKA GLAXOSMITHKLINE INC.)
- COVINGTON & BURLING LLP
- THORN RUN PARTNERS
Bodies those filers lobbied
- HOUSE OF REPRESENTATIVES
- SENATE
- Centers For Medicare and Medicaid Services (CMS)
- Health & Human Services, Dept of (HHS)
- Food & Drug Administration (FDA)
- White House Office
- Executive Office of the President (EOP)
- Patent & Trademark Office (PTO)
Cosponsors
2
Cite this page
U.S. Congress. (2026). H.R. 9661: Expedited Access to Biosimilars Act. 119th Congress. Open America. https://openamerica.io/bill/119-HR-9661/
"H.R. 9661: Expedited Access to Biosimilars Act." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-HR-9661/.
H.R. 9661, 119th Cong. (2026), https://openamerica.io/bill/119-HR-9661/.
[H.R. 9661: Expedited Access to Biosimilars Act](https://openamerica.io/bill/119-HR-9661/)