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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (2)

Short Titles

Short Titles - House of Representatives

Short Titles as Introduced

Pathway for Biosimilars Act

Official Titles

Official Titles - House of Representatives

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.


Actions Overview (1)

Date
03/13/2008 Introduced in House

All Actions (7)

Date
04/14/2008 Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
Action By: Committee on the Judiciary
03/13/2008 Referred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
03/13/2008 Referred to House Judiciary
Action By: House of Representatives
03/13/2008 Referred to House Energy and Commerce
Action By: House of Representatives
03/13/2008 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.
Action By: House of Representatives
03/13/2008 Sponsor introductory remarks on measure. (CR E401-402)
Action By: House of Representatives
03/13/2008 Introduced in House
Action By: House of Representatives

Cosponsors (43)

* = Original cosponsor
CosponsorDate Cosponsored
Rep. Barton, Joe [R-TX-6]* 03/13/2008
Rep. Hill, Baron P. [D-IN-9]* 03/13/2008
Rep. Upton, Fred [R-MI-6]* 03/13/2008
Rep. Wynn, Albert Russell [D-MD-4]* 03/13/2008
Rep. Pitts, Joseph R. [R-PA-16]* 03/13/2008
Rep. Lofgren, Zoe [D-CA-16]* 03/13/2008
Rep. Rogers, Mike J. [R-MI-8]* 03/13/2008
Rep. Capuano, Michael E. [D-MA-8]* 03/13/2008
Rep. Buyer, Steve [R-IN-4]* 03/13/2008
Rep. McGovern, James P. [D-MA-3]* 03/13/2008
Rep. Murphy, Tim [R-PA-18]* 03/13/2008
Rep. Lynch, Stephen F. [D-MA-9]* 03/13/2008
Rep. Ferguson, Mike [R-NJ-7]* 03/13/2008
Rep. Boucher, Rick [D-VA-9] 04/08/2008
Rep. McCarthy, Kevin [R-CA-22] 04/08/2008
Rep. Delahunt, William D. [D-MA-10] 04/15/2008
Rep. Nunes, Devin [R-CA-21] 04/15/2008
Rep. Thompson, Mike [D-CA-1] 04/23/2008
Rep. Bilbray, Brian P. [R-CA-50] 04/23/2008
Rep. Honda, Michael M. [D-CA-15] 04/29/2008
Rep. Walsh, James T. [R-NY-25] 04/30/2008
Rep. Holden, Tim [D-PA-17] 05/07/2008
Rep. Sanchez, Loretta [D-CA-47] 05/08/2008
Rep. Shimkus, John [R-IL-19] 05/14/2008
Rep. Murphy, Patrick J. [D-PA-8] 05/15/2008
Rep. Carson, Andre [D-IN-7] 05/20/2008
Rep. Neal, Richard E. [D-MA-2] 05/22/2008
Rep. Price, David E. [D-NC-4] 05/22/2008
Rep. Souder, Mark E. [R-IN-3] 06/12/2008
Rep. Pence, Mike [R-IN-6] 06/12/2008
Rep. Davis, Susan A. [D-CA-53] 06/17/2008
Rep. Pascrell, Bill, Jr. [D-NJ-8] 06/26/2008
Rep. Brady, Robert A. [D-PA-1] 07/09/2008
Rep. Herger, Wally [R-CA-2] 07/10/2008
Rep. Stearns, Cliff [R-FL-6] 07/29/2008
Rep. Petri, Thomas E. [R-WI-6] 07/31/2008
Rep. Ellsworth, Brad [D-IN-8] 08/01/2008
Rep. Donnelly, Joe [D-IN-2] 09/17/2008
Rep. Gerlach, Jim [R-PA-6] 09/23/2008
Rep. Carney, Christopher P. [D-PA-10] 09/23/2008
Rep. Fattah, Chaka [D-PA-2] 09/26/2008
Rep. Dent, Charles W. [R-PA-15] 09/29/2008
Rep. Holt, Rush [D-NJ-12] 09/29/2008

Committees (2)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
House Energy and Commerce03/13/2008 Referred to
House Energy and Commerce Subcommittee on Health03/13/2008 Referred to
House Judiciary03/13/2008 Referred to
House Judiciary Subcommittee on Courts, the Internet, and Intellectual Property04/14/2008 Referred to

Related Bills (0)

No related bill information was received for H.R.5629.

Subjects (25)

  • Administrative fees
  • Administrative procedure
  • Administrative remedies
  • Child health
  • Clinical trials
  • Confidential communications
  • Department of Health and Human Services
  • Drug approvals
  • Drugs
  • Food and Drug Administration (FDA)
  • Government publicity
  • Intellectual property
  • Licenses
  • Medical supplies
  • Patent infringement
  • Patents
  • Pharmaceutical research
  • Poisons

Latest Summary (1)

There is one summary for H.R.5629. View summaries

Shown Here:
Introduced in House (03/13/2008)

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.