Pathway for Biosimilars Act
Latest action · Apr 14, 2008 Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
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 13, 2008
- 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.
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 43
Members who signed on, in the order they did. Signatures ran from Mar 13, 2008 to Sep 29, 2008; 13 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-MD | Albert Russell Wynn | Original | Mar 13, 2008 |
| D-IN | Baron P. Hill | Original | Mar 13, 2008 |
| R-MI | Fred Upton | Original | Mar 13, 2008 |
| D-MA | James P. McGovern | Original | Mar 13, 2008 |
| R-TX | Joe Barton | Original | Mar 13, 2008 |
| R-PA | Joseph R. Pitts | Original | Mar 13, 2008 |
| D-MA | Michael E. Capuano | Original | Mar 13, 2008 |
| R-NJ | Mike Ferguson | Original | Mar 13, 2008 |
| R-MI | Mike Rogers | Original | Mar 13, 2008 |
| D-MA | Stephen F. Lynch | Original | Mar 13, 2008 |
| R-IN | Steve Buyer | Original | Mar 13, 2008 |
| R-PA | Tim Murphy | Original | Mar 13, 2008 |
| D-CA | Zoe Lofgren | Original | Mar 13, 2008 |
| R-CA | Kevin McCarthy | Apr 8, 2008 | |
| D-VA | Rick Boucher | Apr 8, 2008 | |
| D-MA | Bill Delahunt | Apr 15, 2008 | |
| R-CA | Devin Nunes | Apr 15, 2008 | |
| R-CA | Brian P. Bilbray | Apr 23, 2008 | |
| D-CA | Mike Thompson | Apr 23, 2008 | |
| D-CA | Michael M. Honda | Apr 29, 2008 | |
| R-NY | James T. Walsh | Apr 30, 2008 | |
| D-PA | Tim Holden | May 7, 2008 | |
| D-CA | Loretta Sanchez | May 8, 2008 | |
| R-IL | John Shimkus | May 14, 2008 | |
| D-PA | Patrick J. Murphy | May 15, 2008 | |
| D-IN | André Carson | May 20, 2008 | |
| D-NC | David E. Price | May 22, 2008 | |
| D-MA | Richard E. Neal | May 22, 2008 | |
| R-IN | Mark E. Souder | Jun 12, 2008 | |
| R-IN | Mike Pence | Jun 12, 2008 | |
| D-CA | Susan A. Davis | Jun 17, 2008 | |
| D-NJ | Bill Pascrell, Jr. | Jun 26, 2008 | |
| D-PA | Robert A. Brady | Jul 9, 2008 | |
| R-CA | Wally Herger | Jul 10, 2008 | |
| R-FL | Cliff Stearns | Jul 29, 2008 | |
| R-WI | Thomas E. Petri | Jul 31, 2008 | |
| D-IN | Brad Ellsworth | Aug 1, 2008 | |
| D-IN | Joe Donnelly | Sep 17, 2008 | |
| D-PA | Christopher P. Carney | Sep 23, 2008 | |
| R-PA | Jim Gerlach | Sep 23, 2008 | |
| D-PA | Chaka Fattah | Sep 26, 2008 | |
| R-PA | Charles W. Dent | Sep 29, 2008 | |
| D-NJ | Rush Holt | Sep 29, 2008 |
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 13, 2008 |
| Health Subcommittee | Referred Mar 13, 2008 | |
| House | Judiciary Committee | Referred Mar 13, 2008 |
| Courts, Intellectual Property, Artificial Intelligence, and the Internet Subcommittee | Referred Apr 14, 2008 |
Actions 5
Everything that happened, newest first.
- Apr 14, 2008Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
- Mar 13, 2008Introduced in House
- Mar 13, 2008Sponsor introductory remarks on measure. (CR E401-402)
- Mar 13, 2008Referred 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 13, 2008Referred to the Subcommittee on Health.
In the Congressional Record 1
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| Extensions | Debate and remarks E401 | Anna G. Eshoo D-CA | Mar 13, 2008 |
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.
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.
- Administrative fees
- Administrative procedure
- Administrative remedies
- Child health
- Civil actions and liability
- Clinical trials
- Confidential communications
- Department of Health and Human Services
- Drug approvals
- Drugs
- Economics and Public Finance
- Environmental Protection
- Families
- Food and Drug Administration (FDA)
- Government Operations and Politics
- Government publicity
- Health
- Intellectual property
- Law
- Licenses
- Medical supplies
- Patent infringement
- Patents
- Pharmaceutical research
- Poisons
- Science, Technology, Communications
Text 1
Each version as it was printed, newest first.
- Mar 13, 2008Introduced in House
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.
