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HR 1548 111th Congress House

Pathway for Biosimilars Act

Official title: To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes.

Introduced: July 16, 2009 See on congress.gov
Health Administrative law and regulatory proceduresAdministrative remediesChild healthDepartment of Health and Human Services
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Food and Drug Administration (FDA)Health technology, devices, suppliesIntellectual propertyLicensing and registrationsMedical researchPrescription drugsUser charges and fees
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This bill died when the 111th Congress ended
It never became law before the 111th Congress (2009–2010) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 6 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 18, 2009
Referred to the Subcommittee on Health.
Mar 17, 2009
Referred to House Judiciary
Mar 17, 2009
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Mar 17, 2009
Referred to House Energy and Commerce
Mar 17, 2009
Sponsor introductory remarks on measure. (CR E687-688)
Mar 17, 2009
Introduced in House
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 Latest action March 18, 2009

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Pathway for Biosimilars Act - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).

Requires the Secretary of Health and Human Services to approve the application if: (1) the biological product is biosimilar to the reference product with respect to each condition of use for which the reference product is approved; and (2) the applicant consents to the inspection of the facility that is the subject of the application.

Sets forth requirements for a determination by the Secretary that a biological product is interchangeable with a reference product.

Prohibits a biological product from being evaluated against more than one reference product.

Prohibits licensure under this Act of a biological product containing specified agents or toxins or a schedule I or II controlled substance unless the Secretary determines there would be no increased risk to the security or health of the public from licensing such a biological product.

Prohibits the Secretary from making approval of an application under this Act effective until 12 yeas after the date on which the reference product was first licensed.

Provides for confidentiality of information received pursuant to this Act.

Sets forth provisions governing patent infringement actions related to this Act.

Deems as patent infringement the submission of a statement under this Act by the applicant setting forth reasons why the making, use, or sale of the biosimilar product would not infringe the patent, or why the patent is invalid or unenforceable, if the purpose of such submission is to obtain approval to engage in the commercial manufacture, use, or sale before the expiration of such patent.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 3
 Cosponsors 52
All 52 Democratic 19 Republican 10
D
Clarke, Yvette D.
New York · Oct 29, 2009
 D
Foster, Bill
Illinois · Oct 29, 2009
 D
Peters, Gary C.
Michigan · Sep 22, 2009
Teague, Harry
· Jul 29, 2009
 D
Heinrich, Martin
New Mexico · Jul 28, 2009
 R
Carter, John R.
Texas · Jul 16, 2009
Space, Zachary
· Jul 16, 2009
 D
Murphy, Christopher
Connecticut · Jul 15, 2009
Murphy, Scott
· Jul 13, 2009
 D
Himes, James A.
Connecticut · Jul 10, 2009
 D
Waters, Maxine
California · Jul 9, 2009
Griffith, Parker
· Jul 7, 2009
 R
Smith, Adrian
Nebraska · Jun 24, 2009
Massa, Eric
· Jun 19, 2009
 R
Latta, Robert E.
Ohio · Jun 18, 2009
 D
Davis, Danny K.
Illinois · Jun 16, 2009
 R
Moran, Jerry
Kansas · Jun 16, 2009
Markey, Betsy
· Jun 12, 2009
Lee, Christopher
· Jun 10, 2009
Pierluisi, Pedro
· Jun 9, 2009
 R
Cassidy, Bill
Louisiana · Jun 2, 2009
 R
Graves, Sam
Missouri · Jun 2, 2009
Halvorson, Deborah
· Jun 2, 2009
Cao, Anh
· May 20, 2009
Kratovil, Frank
· May 20, 2009
Adler, John
· May 12, 2009
Hodes, Paul
· May 5, 2009
Kosmas, Suzanne
· May 5, 2009
 D
Courtney, Joe
Connecticut · Apr 23, 2009
McMahon, Michael
· Apr 23, 2009
Kagen, Steve
· Apr 1, 2009
 D
Meeks, Gregory W.
New York · Apr 1, 2009
 R
Sessions, Pete
Texas · Apr 1, 2009
 D
Carson, André
Indiana · Mar 25, 2009
 R
Wilson, Joe
South Carolina · Mar 24, 2009
Carney, Christopher
· Mar 18, 2009
 D
Larson, John B.
Connecticut · Mar 18, 2009
 D
Baldwin, Tammy
Wisconsin · Mar 17, 2009
Bean, Melissa
· Mar 17, 2009
BONO MACK, MARY
· Mar 17, 2009
Ellsworth, Brad
· Mar 17, 2009
HILL, BARON
· Mar 17, 2009
 R
Issa, Darrell
California · Mar 17, 2009
 D
Lofgren, Zoe
California · Mar 17, 2009
 D
Lynch, Stephen F.
Massachusetts · Mar 17, 2009
McCarthy, Kevin
· Mar 17, 2009
 D
McGovern, James P.
Massachusetts · Mar 17, 2009
Murphy, Patrick
· Mar 17, 2009
 D
Neal, Richard E.
Massachusetts · Mar 17, 2009
 R
Scalise, Steve
Louisiana · Mar 17, 2009
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APA
U.S. Congress. (2026). H.R. 1548: Pathway for Biosimilars Act. 111th Congress. Open America. https://openamerica.io/bill/111-HR-1548/
MLA
"H.R. 1548: Pathway for Biosimilars Act." 111th Congress, 2026, Open America, https://openamerica.io/bill/111-HR-1548/.
Bluebook (legal)
H.R. 1548, 111th Cong. (2026), https://openamerica.io/bill/111-HR-1548/.
Markdown link
[H.R. 1548: Pathway for Biosimilars Act](https://openamerica.io/bill/111-HR-1548/)
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