3.0.0 1548 2021-04-19T22:32:31Z 2021-04-19T22:32:31Z House H HR 2009-03-17 111 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2009-03-18T17:39:32Z Referred to 2009-03-17T14:33:49Z hsju00 Judiciary Committee House Standing Referred to 2009-03-17T14:33:50Z 2009-03-18 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2009-03-17 Referred to House Judiciary IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2009-03-17 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 2009-03-17 Referred to House Energy and Commerce IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2009-03-17 Sponsor introductory remarks on measure. (CR E687-688) IntroReferral B00100 9 Library of Congress 2009-03-17 Introduced in House IntroReferral Intro-H 9 Library of Congress 2009-03-17 Introduced in House IntroReferral 1000 9 Library of Congress E000215 Rep. Eshoo, Anna G. [D-CA-14] ANNA ESHOO D CA G. 14 N I000026 Rep. Inslee, Jay [D-WA-1] JAY INSLEE D WA 1 2009-03-17 True B000213 Rep. Barton, Joe [R-TX-6] JOE BARTON R TX L. 6 2009-03-17 True G000410 Rep. Green, Gene [D-TX-29] GENE GREEN D TX 29 2009-03-17 True B001230 Rep. Baldwin, Tammy [D-WI-2] Tammy Baldwin D WI 2 2009-03-17 True R000572 Rep. Rogers, Mike J. [R-MI-8] Mike Rogers R MI 8 2009-03-17 True B001228 Rep. Bono Mack, Mary [R-CA-45] MARY BONO MACK R CA 45 2009-03-17 True H001030 Rep. Hill, Baron P. [D-IN-9] BARON HILL D IN P. 9 2009-03-17 True U000031 Rep. Upton, Fred [R-MI-6] FRED UPTON R MI 6 2009-03-17 True B001252 Rep. Barrow, John [D-GA-12] John Barrow D GA 12 2009-03-17 True P000373 Rep. Pitts, Joseph R. [R-PA-16] JOSEPH PITTS R PA R. 16 2009-03-17 True T000460 Rep. Thompson, Mike [D-CA-1] MIKE THOMPSON D CA 1 2009-03-17 True C001037 Rep. Capuano, Michael E. [D-MA-8] MICHAEL CAPUANO D MA E. 8 2009-03-17 True D000598 Rep. Davis, Susan A. [D-CA-53] SUSAN DAVIS D CA A. 53 2009-03-17 True B000461 Rep. Bilbray, Brian P. [R-CA-50] BRIAN BILBRAY R CA P. 50 2009-03-17 True D000492 Rep. Dreier, David [R-CA-26] DAVID DREIER R CA 26 2009-03-17 True E000289 Rep. Ellsworth, Brad [D-IN-8] Brad Ellsworth D IN 8 2009-03-17 True M000312 Rep. McGovern, James P. [D-MA-3] JAMES MCGOVERN D MA P. 3 2009-03-17 True H000528 Rep. Herger, Wally [R-CA-2] WALLY HERGER R CA 2 2009-03-17 True D000604 Rep. Dent, Charles W. [R-PA-15] Charles Dent R PA W. 15 2009-03-17 True G000549 Rep. Gerlach, Jim [R-PA-6] Jim Gerlach R PA 6 2009-03-17 True B001242 Rep. Bishop, Timothy H. [D-NY-1] Timothy Bishop D NY H. 1 2009-03-17 True L000397 Rep. Lofgren, Zoe [D-CA-16] ZOE LOFGREN D CA 16 2009-03-17 True P000587 Rep. Pence, Mike [R-IN-6] MIKE PENCE R IN 6 2009-03-17 True S001143 Rep. Souder, Mark E. [R-IN-3] MARK SOUDER R IN EDWARD 3 2009-03-17 True H001034 Rep. Honda, Michael M. [D-CA-15] MICHAEL HONDA D CA M. 15 2009-03-17 True T000057 Rep. Tauscher, Ellen O. [D-CA-10] ELLEN TAUSCHER D CA O. 10 2009-03-17 True S001176 Rep. Scalise, Steve [R-LA-1] Steve Scalise R LA 1 2009-03-17 True T000326 Rep. Towns, Edolphus [D-NY-10] EDOLPHUS TOWNS D NY 10 2009-03-17 True C001038 Rep. Crowley, Joseph [D-NY-7] JOSEPH CROWLEY D NY 7 2009-03-17 True I000056 Rep. Issa, Darrell E. [R-CA-49] DARRELL ISSA R CA E. 49 2009-03-17 True M001168 Rep. Murphy, Patrick J. [D-PA-8] Patrick Murphy D PA J. 8 2009-03-17 True B001253 Rep. Bean, Melissa L. [D-IL-8] Melissa Bean D IL L. 8 2009-03-17 True D000210 Rep. Delahunt, Bill [D-MA-10] Bill Delahunt D MA 10 2009-03-17 True S000510 Rep. Smith, Adam [D-WA-9] ADAM SMITH D WA 9 2009-03-17 True M001165 Rep. McCarthy, Kevin [R-CA-22] Kevin McCarthy R CA 22 2009-03-17 True N000015 Rep. Neal, Richard E. [D-MA-2] RICHARD NEAL D MA E. 2 2009-03-17 True L000562 Rep. Lynch, Stephen F. [D-MA-9] Stephen Lynch D MA F. 9 2009-03-17 True D000607 Rep. Donnelly, Joe [D-IN-2] Joe Donnelly D IN 2 2009-03-17 True H000067 Rep. Hall, Ralph M. [R-TX-4] RALPH HALL R TX M. 4 2009-03-17 True L000567 Rep. Lance, Leonard [R-NJ-7] Leonard Lance R NJ 7 2009-03-17 True H001032 Rep. Holt, Rush [D-NJ-12] RUSH HOLT D NJ D. 12 2009-03-17 True N000181 Rep. Nunes, Devin [R-CA-21] Devin Nunes R CA 21 2009-03-17 True K000188 Rep. Kind, Ron [D-WI-3] RON KIND D WI 3 2009-03-17 True S001155 Rep. Sullivan, John [R-OK-1] John Sullivan R OK 1 2009-03-18 False C001065 Rep. Carney, Christopher P. [D-PA-10] Christopher Carney D PA P. 10 2009-03-18 False F000043 Rep. Fattah, Chaka [D-PA-2] CHAKA FATTAH D PA 2 2009-03-18 False H000712 Rep. Holden, Tim [D-PA-17] TIM HOLDEN D PA 17 2009-03-18 False P000096 Rep. Pascrell, Bill, Jr. [D-NJ-8] WILLIAM PASCRELL D NJ J. 8 2009-03-18 False L000557 Rep. Larson, John B. [D-CT-1] JOHN LARSON D CT B. 1 2009-03-18 False S000030 Rep. Sanchez, Loretta [D-CA-47] LORETTA SANCHEZ D CA 47 2009-03-19 False B001227 Rep. Brady, Robert A. [D-PA-1] ROBERT BRADY D PA A. 1 2009-03-24 False W000795 Rep. Wilson, Joe [R-SC-2] Joe Wilson R SC 2 2009-03-24 False P000265 Rep. Petri, Thomas E. [R-WI-6] TOM PETRI R WI 6 2009-03-24 False C001072 Rep. Carson, Andre [D-IN-7] Andre Carson D IN 7 2009-03-25 False S000250 Rep. Sessions, Pete [R-TX-32] PETE SESSIONS R TX 32 2009-04-01 False M001137 Rep. Meeks, Gregory W. [D-NY-6] GREGORY MEEKS D NY W. 6 2009-04-01 False K000365 Rep. Kagen, Steve [D-WI-8] Steve Kagen D WI 8 2009-04-01 False R000435 Rep. Ros-Lehtinen, Ileana [R-FL-18] ILEANA ROS-LEHTINEN R FL 18 2009-04-01 False P000523 Rep. Price, David E. [D-NC-4] DAVID PRICE D NC E. 4 2009-04-02 False M001147 Rep. McCotter, Thaddeus G. [R-MI-11] Thaddeus McCotter R MI G. 11 2009-04-22 False S001171 Rep. Shuler, Heath [D-NC-11] Heath Shuler D NC 11 2009-04-22 False B001232 Rep. Biggert, Judy [R-IL-13] JUDY BIGGERT R IL 13 2009-04-22 False C001069 Rep. Courtney, Joe [D-CT-2] Joe Courtney D CT 2 2009-04-23 False S001162 Rep. Schwartz, Allyson Y. [D-PA-13] Allyson Schwartz D PA Y. 13 2009-04-23 False M001174 Rep. McMahon, Michael E. [D-NY-13] Michael McMahon D NY E. 13 2009-04-23 False W000413 Rep. Whitfield, Ed [R-KY-1] EDWARD WHITFIELD R KY 1 2009-04-27 False M001161 Rep. Melancon, Charlie [D-LA-3] Charlie Melancon D LA 3 2009-05-04 False K000370 Rep. Kosmas, Suzanne M. [D-FL-24] Suzanne Kosmas D FL M. 24 2009-05-05 False H001043 Rep. Hodes, Paul W. [D-NH-2] Paul Hodes D NH W. 2 2009-05-05 False W000791 Rep. Walden, Greg [R-OR-2] GREG WALDEN R OR 2 2009-05-11 False N000182 Rep. Neugebauer, Randy [R-TX-19] Randy Neugebauer R TX 19 2009-05-12 False A000362 Rep. Altmire, Jason [D-PA-4] Jason Altmire D PA 4 2009-05-12 False A000364 Rep. Adler, John H. [D-NJ-3] John Adler D NJ H. 3 2009-05-12 False E000063 Rep. Edwards, Chet [D-TX-17] CHET EDWARDS D TX 17 2009-05-13 False J000174 Rep. Johnson, Sam [R-TX-3] SAM JOHNSON R TX 3 2009-05-18 False M001120 Rep. Murtha, John P. [D-PA-12] JOHN MURTHA D PA P. 12 2009-05-20 False C001079 Rep. Cao, Anh "Joseph" [R-LA-2] Anh Cao R LA "Joseph" 2 2009-05-20 False K000371 Rep. Kratovil, Frank, Jr. [D-MD-1] Frank Kratovil D MD 1 2009-05-20 False H001044 Rep. Halvorson, Deborah L. [D-IL-11] Deborah Halvorson D IL L. 11 2009-06-02 False C001075 Rep. Cassidy, Bill [R-LA-6] Bill Cassidy R LA 6 2009-06-02 False M001159 Rep. McMorris Rodgers, Cathy [R-WA-5] Cathy McMorris Rodgers R WA 5 2009-06-02 False G000544 Rep. Gonzalez, Charles A. [D-TX-20] CHARLES GONZALEZ D TX A. 20 2009-06-02 False G000546 Rep. Graves, Sam [R-MO-6] SAM GRAVES R MO 6 2009-06-02 False R000582 Rep. Roe, David P. [R-TN-1] David Roe R TN P. 1 2009-06-02 False B001251 Rep. Butterfield, G. K. [D-NC-1] G. K. Butterfield D NC 1 2009-06-04 False L000111 Rep. Latham, Tom [R-IA-4] TOM LATHAM R IA 4 2009-06-04 False M001142 Rep. Matheson, Jim [D-UT-2] JIM MATHESON D UT 2 2009-06-04 False P000596 Resident Commissioner Pierluisi, Pedro R. [D-PR-At Large] Pedro Pierluisi D PR R. 0 2009-06-09 False A000361 Rep. Alexander, Rodney [R-LA-5] Rodney Alexander R LA 5 2009-06-10 False L000517 Rep. Lungren, Daniel E. [R-CA-3] DANIEL LUNGREN R CA EDWARD 3 2009-06-10 False L000568 Rep. Lee, Christopher J. [R-NY-26] Christopher Lee R NY J. 26 2009-06-10 False S001175 Rep. Speier, Jackie [D-CA-12] Jackie Speier D CA 12 2009-06-10 False B000716 Rep. Boyd, Allen [D-FL-2] ALLEN BOYD D FL JR. 2 2009-06-12 False M001172 Rep. Markey, Betsy [D-CO-4] Betsy Markey D CO 4 2009-06-12 False M001149 Rep. Michaud, Michael H. [D-ME-2] Michael Michaud D ME H. 2 2009-06-12 False G000556 Rep. Grayson, Alan [D-FL-8] Alan Grayson D FL 8 2009-06-12 False T000462 Rep. Tiberi, Patrick J. [R-OH-12] PATRICK TIBERI R OH J. 12 2009-06-12 False G000548 Rep. Garrett, Scott [R-NJ-5] Scott Garrett R NJ 5 2009-06-15 False F000030 Rep. Farr, Sam [D-CA-17] SAM FARR D CA 17 2009-06-15 False D000096 Rep. Davis, Danny K. [D-IL-7] DANNY DAVIS D IL K. 7 2009-06-16 False M000934 Rep. Moran, Jerry [R-KS-1] Jerry Moran R KS 1 2009-06-16 False K000369 Rep. Kissell, Larry [D-NC-8] Larry Kissell D NC 8 2009-06-18 False L000566 Rep. Latta, Robert E. [R-OH-5] Robert Latta R OH E. 5 2009-06-18 False M001173 Rep. Massa, Eric J. J. [D-NY-29] Eric Massa D NY J. J. 29 2009-06-19 False C000556 Rep. Coble, Howard [R-NC-6] HOWARD COBLE R NC 6 2009-06-23 False S001179 Rep. Schock, Aaron [R-IL-18] Aaron Schock R IL 18 2009-06-23 False S001172 Rep. Smith, Adrian [R-NE-3] Adrian Smith R NE 3 2009-06-24 False B001203 Rep. Buyer, Steve [R-IN-4] STEPHEN BUYER R IN E. 4 2009-06-26 False B001234 Rep. Baca, Joe [D-CA-43] JOE BACA D CA 43 2009-07-07 False R000581 Rep. Richardson, Laura [D-CA-37] Laura Richardson D CA 37 2009-07-07 False R000580 Rep. Roskam, Peter J. [R-IL-6] Peter Roskam R IL J. 6 2009-07-07 False G000557 Rep. Griffith, Parker [D-AL-5] Parker Griffith D AL 5 2009-07-07 False B000208 Rep. Bartlett, Roscoe G. [R-MD-6] ROSCOE BARTLETT R MD G. 6 2009-07-08 False M001154 Rep. Miller, Brad [D-NC-13] Brad Miller D NC 13 2009-07-09 False H000324 Rep. Hastings, Alcee L. [D-FL-23] ALCEE HASTINGS D FL L. 23 2009-07-09 False W000738 Rep. Woolsey, Lynn C. [D-CA-6] LYNN WOOLSEY D CA 6 2009-07-09 False A000365 Rep. Austria, Steve [R-OH-7] Steve Austria R OH 7 2009-07-09 False C000714 Rep. Conyers, John, Jr. [D-MI-14] JOHN CONYERS D MI 14 2009-07-09 False W000793 Rep. Wu, David [D-OR-1] DAVID WU D OR 1 2009-07-09 False K000113 Rep. Kennedy, Patrick J. [D-RI-1] PATRICK KENNEDY D RI J. 1 2009-07-09 False C001078 Rep. Connolly, Gerald E. [D-VA-11] Gerald Connolly D VA E. 11 2009-07-09 False W000187 Rep. Waters, Maxine [D-CA-35] MAXINE WATERS D CA 35 2009-07-09 False R000578 Rep. Reichert, David G. [R-WA-8] David Reichert R WA G. 8 2009-07-09 False M001156 Rep. McHenry, Patrick T. [R-NC-10] Patrick McHenry R NC 10 2009-07-09 False B001255 Rep. Boustany, Charles W., Jr. [R-LA-7] Charles Boustany R LA W. 7 2009-07-09 False R000571 Rep. Rehberg, Denny [R-MT-At Large] DENNY REHBERG R MT 0 2009-07-10 False H001047 Rep. Himes, James A. [D-CT-4] James Himes D CT A. 4 2009-07-10 False O000168 Rep. Olson, Pete [R-TX-22] Pete Olson R TX 22 2009-07-13 False R000568 Rep. Rodriguez, Ciro D. [D-TX-23] CIRO RODRIGUEZ D TX D. 23 2009-07-13 False M001178 Rep. Murphy, Scott [D-NY-20] Scott Murphy D NY 20 2009-07-13 False T000038 Rep. Tanner, John S. [D-TN-8] JOHN TANNER D TN 8 2009-07-13 False M001169 Rep. Murphy, Christopher [D-CT-5] Christopher Murphy D CT S. 5 2009-07-15 False S000822 Rep. Stearns, Cliff [R-FL-6] CLIFF STEARNS R FL 6 2009-07-15 False C001064 Rep. Campbell, John [R-CA-48] John Campbell R CA 48 2009-07-16 False C001051 Rep. Carter, John R. [R-TX-31] John Carter R TX R. 31 2009-07-16 False S001173 Rep. Space, Zachary T. [D-OH-18] Zachary Space D OH T. 18 2009-07-16 False R000576 Rep. Ruppersberger, C. A. Dutch [D-MD-2] C. A. Ruppersberger D MD Dutch 2 2009-07-20 False C001062 Rep. Conaway, K. Michael [R-TX-11] K. Conaway R TX Michael 11 2009-07-22 False B001149 Rep. Burton, Dan [R-IN-5] DAN BURTON R IN 5 2009-07-22 False K000008 Rep. Kanjorski, Paul E. [D-PA-11] PAUL KANJORSKI D PA E. 11 2009-07-28 False H001046 Rep. Heinrich, Martin [D-NM-1] Martin Heinrich D NM T. 1 2009-07-28 False T000466 Rep. Teague, Harry [D-NM-2] Harry Teague D NM 2 2009-07-29 False P000595 Rep. Peters, Gary C. [D-MI-9] Gary Peters D MI 9 2009-09-22 False L000569 Rep. Luetkemeyer, Blaine [R-MO-9] Blaine Luetkemeyer R MO 9 2009-09-29 False M000933 Rep. Moran, James P. [D-VA-8] JAMES MORAN D VA P. 8 2009-10-07 False T000459 Rep. Terry, Lee [R-NE-2] LEE TERRY R NE 2 2009-10-27 False F000454 Rep. Foster, Bill [D-IL-14] Bill Foster D IL 14 2009-10-29 False C001067 Rep. Clarke, Yvette D. [D-NY-11] Yvette Clarke D NY D. 11 2009-10-29 False C000243 Rep. Castle, Michael N. [R-DE-At Large] MICHAEL CASTLE R DE N. 0 2009-11-03 False Health Administrative law and regulatory procedures Administrative remedies Child health Department of Health and Human Services Food and Drug Administration (FDA) Health technology, devices, supplies Intellectual property Licensing and registrations Medical research Prescription drugs User charges and fees Health 00 2009-03-17 Introduced in House 2009-04-28T19:01:39Z 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.

]]> 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 2009-03-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111hr1548ih/xml/BILLS-111hr1548ih.xml 2009-03-18 Referred to the Subcommittee on Health. 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.