United States Government Publishing Office
publisher
pbl
distributor
dst
United States
Congress
House of Representatives
author
aut
Government Organization
text
government publication
eng
BILLS
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.;Expedited Access to Biosimilars Act;H.R. 9661 (IH)
Bills and Statutes
119_cong_bills
legislative
2026-07-16
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.
Expedited Access to Biosimilars Act
H.R. 9661 (IH)
U.S. Government Publishing Office
2026-07-14
monographic
deposited
born digital
4 p.
Y 1.6:
Y 1.4/6:
P0b002ee1e5121a67
https://www.govinfo.gov/app/details/BILLS-119hr9661ih
H.R. 9661
021-610-00252-9
000501532
000325573
Congressional bills
House bills
f:h9661_ih.txt
https://www.govinfo.gov/app/details/BILLS-119hr9661ih
https://www.govinfo.gov/content/pkg/BILLS-119hr9661ih/html/BILLS-119hr9661ih.htm
https://www.govinfo.gov/content/pkg/BILLS-119hr9661ih/pdf/BILLS-119hr9661ih.pdf
https://www.govinfo.gov/content/pkg/BILLS-119hr9661ih/xml/BILLS-119hr9661ih.xml
fdlp
DGPO
2026-07-16
2026-07-16
BILLS-119hr9661ih
machine generated
eng
Nicholas A. Langworthy
United States House of Representatives
sponsor
spn
United States Congress Member
Kim Schrier
United States House of Representatives
cosponsor
United States Congress Member
United States
Congress
House of Representatives
Committee on Energy and Commerce
associated name
asn
United States Code
Title 42 Section 262(k)
Title 42 Section 262(k)(2)(A)
Title 42 Section 262(k)(5)
42 U.S.C. 262(k)
42 U.S.C. 262(k)(2)(A)
42 U.S.C. 262(k)(5)
hr
BILLS-119hr9661ih
119
2
HOUSE
HOUSE
9661
ih
ih
Expedited Access to Biosimilars Act
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.
Mr. Langworthy (for himself and Ms. Schrier) introduced the following bill; which was referred to the Committee on Energy and Commerce
Committee on Energy and Commerce
Energy and Commerce
Mr. Langworthy
Nicholas A. Langworthy
Langworthy, Nicholas A.
Nicholas Langworthy
Ms. Schrier
Kim Schrier
Schrier, Kim
false
false