3.0.0 5629 2021-06-07T20:01:51Z 2021-06-07T20:01:51Z House H HR 2008-03-13 110 hsju00 Judiciary Committee House Standing hsju03 Courts, Intellectual Property, and the Internet Subcommittee Referred to 2008-04-14T19:25:40Z Referred to 2008-03-13T14:35:10Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2008-03-13T20:43:07Z Referred to 2008-03-13T14:35:05Z 2008-04-14 hsju03 Courts, Intellectual Property, and the Internet Subcommittee 1 House committee actions Referred to the Subcommittee on Courts, the Internet, and Intellectual Property. Committee 2008-03-13 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2008-03-13 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. IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2008-03-13 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. IntroReferral H11100-A 9 Library of Congress 2008-03-13 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. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2008-03-13 Sponsor introductory remarks on measure. (CR E401-402) IntroReferral B00100 9 Library of Congress 2008-03-13 Introduced in House IntroReferral Intro-H 9 Library of Congress 2008-03-13 Introduced in House IntroReferral 1000 9 Library of Congress E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 N B000213 Rep. Barton, Joe [R-TX-6] JOE BARTON R TX L. 6 2008-03-13 True H001030 Rep. Hill, Baron P. [D-IN-9] BARON HILL D IN P. 9 2008-03-13 True U000031 Rep. Upton, Fred [R-MI-6] FRED UPTON R MI 6 2008-03-13 True W000784 Rep. Wynn, Albert Russell [D-MD-4] ALBERT WYNN D MD R. 4 2008-03-13 True P000373 Rep. Pitts, Joseph R. [R-PA-16] JOSEPH PITTS R PA R. 16 2008-03-13 True L000397 Rep. Lofgren, Zoe [D-CA-16] ZOE LOFGREN D CA 16 2008-03-13 True R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 2008-03-13 True C001037 Rep. Capuano, Michael E. [D-MA-8] MICHAEL CAPUANO D MA E. 8 2008-03-13 True B001203 Rep. Buyer, Steve [R-IN-4] STEPHEN BUYER R IN E. 4 2008-03-13 True M000312 Rep. McGovern, James P. [D-MA-3] JAMES MCGOVERN D MA P. 3 2008-03-13 True M001151 Rep. Murphy, Tim [R-PA-18] Tim Murphy R PA 18 2008-03-13 True L000562 Rep. Lynch, Stephen F. [D-MA-9] Stephen Lynch D MA F. 9 2008-03-13 True F000443 Rep. Ferguson, Mike [R-NJ-7] MIKE FERGUSON R NJ 7 2008-03-13 True B000657 Rep. Boucher, Rick [D-VA-9] RICK BOUCHER D VA 9 2008-04-08 False M001165 Rep. McCarthy, Kevin [R-CA-22] Kevin McCarthy R CA 22 2008-04-08 False D000210 Rep. Delahunt, William D. [D-MA-10] William Delahunt D MA D. 10 2008-04-15 False N000181 Rep. Nunes, Devin [R-CA-21] Devin Nunes R CA 21 2008-04-15 False T000460 Rep. Thompson, Mike [D-CA-1] MIKE THOMPSON D CA 1 2008-04-23 False B000461 Rep. Bilbray, Brian P. [R-CA-50] BRIAN BILBRAY R CA P. 50 2008-04-23 False H001034 Rep. Honda, Michael M. [D-CA-15] MICHAEL HONDA D CA M. 15 2008-04-29 False W000099 Rep. Walsh, James T. [R-NY-25] JAMES WALSH R NY T. 25 2008-04-30 False H000712 Rep. Holden, Tim [D-PA-17] TIM HOLDEN D PA 17 2008-05-07 False S000030 Rep. Sanchez, Loretta [D-CA-47] LORETTA SANCHEZ D CA 47 2008-05-08 False S000364 Rep. Shimkus, John [R-IL-19] JOHN SHIMKUS R IL M. 19 2008-05-14 False M001168 Rep. Murphy, Patrick J. [D-PA-8] Patrick Murphy D PA J. 8 2008-05-15 False C001072 Rep. Carson, Andre [D-IN-7] Andre Carson D IN 7 2008-05-20 False N000015 Rep. Neal, Richard E. [D-MA-2] RICHARD NEAL D MA E. 2 2008-05-22 False P000523 Rep. Price, David E. [D-NC-4] DAVID PRICE D NC E. 4 2008-05-22 False S001143 Rep. Souder, Mark E. [R-IN-3] MARK SOUDER R IN EDWARD 3 2008-06-12 False P000587 Rep. Pence, Mike [R-IN-6] MIKE PENCE R IN 6 2008-06-12 False D000598 Rep. Davis, Susan A. [D-CA-53] SUSAN DAVIS D CA A. 53 2008-06-17 False P000096 Rep. Pascrell, Bill, Jr. [D-NJ-8] WILLIAM PASCRELL D NJ J. 8 2008-06-26 False B001227 Rep. Brady, Robert A. [D-PA-1] ROBERT BRADY D PA A. 1 2008-07-09 False H000528 Rep. Herger, Wally [R-CA-2] WALLY HERGER R CA 2 2008-07-10 False S000822 Rep. Stearns, Cliff [R-FL-6] CLIFF STEARNS R FL 6 2008-07-29 False P000265 Rep. Petri, Thomas E. [R-WI-6] TOM PETRI R WI 6 2008-07-31 False E000289 Rep. Ellsworth, Brad [D-IN-8] Brad Ellsworth D IN 8 2008-08-01 False D000607 Rep. Donnelly, Joe [D-IN-2] Joe Donnelly D IN 2 2008-09-17 False G000549 Rep. Gerlach, Jim [R-PA-6] Jim Gerlach R PA 6 2008-09-23 False C001065 Rep. Carney, Christopher P. [D-PA-10] Christopher Carney D PA P. 10 2008-09-23 False F000043 Rep. Fattah, Chaka [D-PA-2] CHAKA FATTAH D PA 2 2008-09-26 False D000604 Rep. Dent, Charles W. [R-PA-15] Charles Dent R PA W. 15 2008-09-29 False H001032 Rep. Holt, Rush [D-NJ-12] RUSH HOLT D NJ D. 12 2008-09-29 False 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 Intellectual property Law Licenses Medical supplies Patent infringement Patents Pharmaceutical research Poisons Science, Technology, Communications Health 00 2008-03-13 Introduced in House 2008-04-16T20:52:53Z 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.

]]> Pathway for Biosimilars Act Short Titles as Introduced Pathway for Biosimilars Act Display Title Pathway for Biosimilars Act 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. Introduced in House 2008-03-13T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr5629ih/xml/BILLS-110hr5629ih.xml 2008-04-14 Referred to the Subcommittee on Courts, the Internet, and Intellectual Property. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.