HR 1548 · 111th Congress 2009–2011, ended

Pathway for Biosimilars Act

Introduced Mar 17, 2009 Originated House Sponsor Anna G. Eshoo D-CA

Latest action · Mar 18, 2009 Referred to the Subcommittee on Health.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

IntroducedMar 17, 2009
Passed HouseNot reached
Passed SenateNot reached
To the PresidentNot reached
Became lawNot reached

Summary

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.

Cosponsors 149

Members who signed on, in the order they did. Signatures ran from Mar 17, 2009 to Nov 3, 2009; 43 are original cosponsors, there from the day it was introduced.

Seat	Cosponsor		Signed on
D-WA	Adam Smith	Original	Mar 17, 2009
D-IN	Baron P. Hill	Original	Mar 17, 2009
D-MA	Bill Delahunt	Original	Mar 17, 2009
D-IN	Brad Ellsworth	Original	Mar 17, 2009
R-CA	Brian P. Bilbray	Original	Mar 17, 2009
R-PA	Charles W. Dent	Original	Mar 17, 2009
R-CA	Darrell Issa	Original	Mar 17, 2009
R-CA	David Dreier	Original	Mar 17, 2009
R-CA	Devin Nunes	Original	Mar 17, 2009
D-NY	Edolphus Towns	Original	Mar 17, 2009
D-CA	Ellen O. Tauscher	Original	Mar 17, 2009
R-MI	Fred Upton	Original	Mar 17, 2009
D-TX	Gene Green	Original	Mar 17, 2009
D-MA	James P. McGovern	Original	Mar 17, 2009
D-WA	Jay Inslee	Original	Mar 17, 2009
R-PA	Jim Gerlach	Original	Mar 17, 2009
R-TX	Joe Barton	Original	Mar 17, 2009
D-IN	Joe Donnelly	Original	Mar 17, 2009
D-GA	John Barrow	Original	Mar 17, 2009
D-NY	Joseph Crowley	Original	Mar 17, 2009
R-PA	Joseph R. Pitts	Original	Mar 17, 2009
R-CA	Kevin McCarthy	Original	Mar 17, 2009
R-NJ	Leonard Lance	Original	Mar 17, 2009
R-IN	Mark E. Souder	Original	Mar 17, 2009
R-CA	Mary Bono	Original	Mar 17, 2009
D-IL	Melissa L. Bean	Original	Mar 17, 2009
D-MA	Michael E. Capuano	Original	Mar 17, 2009
D-CA	Michael M. Honda	Original	Mar 17, 2009
R-IN	Mike Pence	Original	Mar 17, 2009
R-MI	Mike Rogers	Original	Mar 17, 2009
D-CA	Mike Thompson	Original	Mar 17, 2009
D-PA	Patrick J. Murphy	Original	Mar 17, 2009
R-TX	Ralph M. Hall	Original	Mar 17, 2009
D-MA	Richard E. Neal	Original	Mar 17, 2009
D-WI	Ron Kind	Original	Mar 17, 2009
D-NJ	Rush Holt	Original	Mar 17, 2009
D-MA	Stephen F. Lynch	Original	Mar 17, 2009
R-LA	Steve Scalise	Original	Mar 17, 2009
D-CA	Susan A. Davis	Original	Mar 17, 2009
D-WI	Tammy Baldwin	Original	Mar 17, 2009
D-NY	Timothy H. Bishop	Original	Mar 17, 2009
R-CA	Wally Herger	Original	Mar 17, 2009
D-CA	Zoe Lofgren	Original	Mar 17, 2009
D-NJ	Bill Pascrell, Jr.		Mar 18, 2009
D-PA	Chaka Fattah		Mar 18, 2009
D-PA	Christopher P. Carney		Mar 18, 2009
D-CT	John B. Larson		Mar 18, 2009
R-OK	John Sullivan		Mar 18, 2009
D-PA	Tim Holden		Mar 18, 2009
D-CA	Loretta Sanchez		Mar 19, 2009
R-SC	Joe Wilson		Mar 24, 2009
D-PA	Robert A. Brady		Mar 24, 2009
R-WI	Thomas E. Petri		Mar 24, 2009
D-IN	André Carson		Mar 25, 2009
D-NY	Gregory W. Meeks		Apr 1, 2009
R-FL	Ileana Ros-Lehtinen		Apr 1, 2009
R-TX	Pete Sessions		Apr 1, 2009
D-WI	Steve Kagen		Apr 1, 2009
D-NC	David E. Price		Apr 2, 2009
D-NC	Heath Shuler		Apr 22, 2009
R-IL	Judy Biggert		Apr 22, 2009
R-MI	Thaddeus G. McCotter		Apr 22, 2009
D-PA	Allyson Y. Schwartz		Apr 23, 2009
D-CT	Joe Courtney		Apr 23, 2009
D-NY	Michael E. McMahon		Apr 23, 2009
R-KY	Ed Whitfield		Apr 27, 2009
D-LA	Charlie Melancon		May 4, 2009
D-NH	Paul W. Hodes		May 5, 2009
D-FL	Suzanne M. Kosmas		May 5, 2009
R-OR	Greg Walden		May 11, 2009
D-PA	Jason Altmire		May 12, 2009
D-NJ	John H. Adler		May 12, 2009
R-TX	Randy Neugebauer		May 12, 2009
D-TX	Chet Edwards		May 13, 2009
R-TX	Sam Johnson		May 18, 2009
R-LA	Anh "Joseph" Cao		May 20, 2009
D-MD	Frank Kratovil, Jr.		May 20, 2009
D-PA	John P. Murtha		May 20, 2009
R-LA	Bill Cassidy		Jun 2, 2009
R-WA	Cathy McMorris Rodgers		Jun 2, 2009
D-TX	Charles A. Gonzalez		Jun 2, 2009
R-TN	David P. Roe		Jun 2, 2009
D-IL	Deborah L. Halvorson		Jun 2, 2009
R-MO	Sam Graves		Jun 2, 2009
D-NC	G. K. Butterfield		Jun 4, 2009
D-UT	Jim Matheson		Jun 4, 2009
R-IA	Tom Latham		Jun 4, 2009
D-PR	Pedro R. Pierluisi		Jun 9, 2009
R-NY	Christopher J. Lee		Jun 10, 2009
R-CA	Daniel E. Lungren		Jun 10, 2009
D-CA	Jackie Speier		Jun 10, 2009
R-LA	Rodney Alexander		Jun 10, 2009
D-FL	Alan Grayson		Jun 12, 2009
D-FL	Allen Boyd		Jun 12, 2009
D-CO	Betsy Markey		Jun 12, 2009
D-ME	Michael H. Michaud		Jun 12, 2009
R-OH	Patrick J. Tiberi		Jun 12, 2009
D-CA	Sam Farr		Jun 15, 2009
R-NJ	Scott Garrett		Jun 15, 2009
D-IL	Danny K. Davis		Jun 16, 2009
R-KS	Jerry Moran		Jun 16, 2009
D-NC	Larry Kissell		Jun 18, 2009
R-OH	Robert E. Latta		Jun 18, 2009
D-NY	Eric J. J. Massa		Jun 19, 2009
R-IL	Aaron Schock		Jun 23, 2009
R-NC	Howard Coble		Jun 23, 2009
R-NE	Adrian Smith		Jun 24, 2009
R-IN	Steve Buyer		Jun 26, 2009
D-CA	Joe Baca		Jul 7, 2009
D-CA	Laura Richardson		Jul 7, 2009
R-AL	Parker Griffith		Jul 7, 2009
R-IL	Peter J. Roskam		Jul 7, 2009
R-MD	Roscoe G. Bartlett		Jul 8, 2009
D-FL	Alcee L. Hastings		Jul 9, 2009
D-NC	Brad Miller		Jul 9, 2009
R-LA	Charles W. Boustany, Jr.		Jul 9, 2009
R-WA	David G. Reichert		Jul 9, 2009
D-OR	David Wu		Jul 9, 2009
D-VA	Gerald E. Connolly		Jul 9, 2009
D-MI	John Conyers, Jr.		Jul 9, 2009
D-CA	Lynn C. Woolsey		Jul 9, 2009
D-CA	Maxine Waters		Jul 9, 2009
D-RI	Patrick J. Kennedy		Jul 9, 2009
R-NC	Patrick T. McHenry		Jul 9, 2009
R-OH	Steve Austria		Jul 9, 2009
R-MT	Denny Rehberg		Jul 10, 2009
D-CT	James A. Himes		Jul 10, 2009
D-TX	Ciro D. Rodriguez		Jul 13, 2009
D-TN	John S. Tanner		Jul 13, 2009
R-TX	Pete Olson		Jul 13, 2009
D-NY	Scott Murphy		Jul 13, 2009
D-CT	Christopher Murphy		Jul 15, 2009
R-FL	Cliff Stearns		Jul 15, 2009
R-CA	John Campbell		Jul 16, 2009
R-TX	John R. Carter		Jul 16, 2009
D-OH	Zachary T. Space		Jul 16, 2009
D-MD	C. A. Dutch Ruppersberger		Jul 20, 2009
R-IN	Dan Burton		Jul 22, 2009
R-TX	K. Michael Conaway		Jul 22, 2009
D-NM	Martin Heinrich		Jul 28, 2009
D-PA	Paul E. Kanjorski		Jul 28, 2009
D-NM	Harry Teague		Jul 29, 2009
D-MI	Gary C. Peters		Sep 22, 2009
R-MO	Blaine Luetkemeyer		Sep 29, 2009
D-VA	James P. Moran		Oct 7, 2009
R-NE	Lee Terry		Oct 27, 2009
D-IL	Bill Foster		Oct 29, 2009
D-NY	Yvette D. Clarke		Oct 29, 2009
R-DE	Michael N. Castle		Nov 3, 2009

Committees 2

Where it was sent and what each committee and subcommittee did with it, in order.

Chamber	Committee	What it did
House	Energy and Commerce Committee	Referred Mar 17, 2009
	Health Subcommittee	Referred Mar 18, 2009
House	Judiciary Committee	Referred Mar 17, 2009

Actions 6

Everything that happened, newest first.

Mar 18, 2009Referred to the Subcommittee on Health.
Mar 17, 2009Introduced in House
Mar 17, 2009Sponsor introductory remarks on measure. (CR E687-688)
Mar 17, 2009Referred to House Energy and Commerce
Mar 17, 2009Referred 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.

Show all 6 actions

Research

What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.

Printed hearings 3

Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.

Number	Hearing	Committee	Held
Serial No. 111-73	BIOLOGICS AND BIOSIMILARS: BALANCING INCENTIVES FOR INNOVATION256 pages	Judiciary Committee	Jul 14, 2009
Serial No. 111-54	COMPREHENSIVE HEALTH CARE REFORM DISCUSSION DRAFT1,055 pages	Energy and Commerce Committee	Jun 23, 2009–Jun 25, 2009
Serial No. 111-46	EMERGING HEALTH CARE ISSUES: FOLLOW-ON BIOLOGIC DRUG COMPETITION289 pages	Energy and Commerce Committee	Jun 11, 2009

CRS reports 1

Congressional Research Service work that CRS links to this bill or the law it became, newest first.

Cite it 1

Products on other subjects that cite it, usually among other measures.

Product	Title	Kind	Published
RL34045	FDA Regulation of Follow-On Biologics Archived	Report	Apr 26, 2010

Titles 2

Every title it has carried, official and short, at each stage.

Official Title as Introduced: To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes.
Short Titles as Introduced: Pathway for Biosimilars Act

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

Mar 17, 2009Introduced in House

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.