h 49688 1205380800 false 1208145600 5629 983 110 400124

3/13/2008--Introduced.<br/>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).<br/>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.<br/>Prohibits a biological product from being evaluated against more than one reference product.<br/>Prohibits licensure under this Act of a biological product containing specified agents or toxins.<br/>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.<br/>Provides for confidentiality of information received pursuant to this Act.<br/>Sets forth provisions governing patent infringement actions related to this Act.<br/>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.<br/>

1208145600 2008-04-14 Fri Nov 07 05:38:01 -0600 2008 introduced 49688 'act':4 'pathway':1 'biosimilar':3 58982 false short introduced 49688 'act':7 'amend':2 'biolog':17 'health':5 'public':4 'purpos':22 'servic':6 'pathway':11 'product':18 'licensur':14 'establish':9 'biosimilar':16 57827 false official action 49688 1208145600 Mon Apr 14 00:00:00 -0500 2008 165027 Referred to the Subcommittee on Courts, the Internet, and Intellectual Property. E000215 1942-12-13 205 Cannon House Office Building https://forms.house.gov/eshoo/webforms/issue_subscribe.htm 14 202-225-8890 Anna 'd':4 'ca':5 '-14':6 'rep':1 'anna':2,7,9 'eshoo':3,8,10 F 400124 Eshoo Anna_G._Eshoo G. Rep. Anna Eshoo [D, CA-14] N00007335 7650 Democrat 202-225-8104 Catholic CA Anna Eshoo 2.8 http://eshoo.house.gov/ RepAnnaEshoo B000213 1949-09-15 2109 Rayburn House Office Building http://joebarton.house.gov/ContactJoe.aspx?Type=Email 6 202-225-3052 Joe 'r':4 '-6':6 'tx':5 'joe':2,7,9 'rep':1 'barton':3,8,10 M 400018 Barton Joe_Barton Linus Rep. Joe Barton [R, TX-6] N00005656 6780 Republican 202-225-2002 Methodist TX Joe Barton 5.0 http://joebarton.house.gov/ B000461 1951-01-28 227 Cannon House Office Building http://www.house.gov/bilbray/contact.shtml 50 202-225-2558 Brian 'r':4 'ca':5 '-50':6 'rep':1 'brian':2,7,9 'bilbray':3,8,10 M 400570 Bilbray Brian_Bilbray P. Rep. Brian Bilbray [R, CA-50] N00006981 6614 Republican 202-225-0508 Catholic CA Brian Bilbray 5.88888888888889 http://www.house.gov/bilbray/ B000657 1946-08-01 2187 Rayburn House Office Building http://www.boucher.house.gov/index.php?option=com_content&task=view&id=645&Itemid= 9 202-225-0442 Frederick 'd':4 '-9':6 'va':5 'rep':1 'rick':9 'boucher':3,8,11 'frederick':2,7,10 M 400043 Boucher Rick_Boucher C. Rep. Frederick Boucher [D, VA-9] Rick N00002171 6692 Democrat 202-225-3861 Methodist VA Rick Frederick Boucher 3.38461538461538 http://www.boucher.house.gov/ B001227 1945-04-07 206 Cannon House Office Building http://www.house.gov/formrobertbrady/issue.htm 1 202-225-0088 Robert 'd':4 '-1':6 'pa':5 'rep':1 'bradi':3,8,10 'robert':2,7,9 M 400047 Brady Robert_A._Brady A. Rep. Robert Brady [D, PA-1] N00001619 6484 Democrat 202-225-4731 PA Bob Robert Brady 1.625 http://www.house.gov/robertbrady/ B001203 1958-11-26 2230 Rayburn House Office Building http://www.house.gov/writerep/ 4 202-225-2267 Stephen 'r':4 '-4':6 'rep':1 'buyer':3,8,11 'steve':9 'stephen':2,7,10 M 400056 Buyer Steve_Buyer E. Rep. Stephen Buyer [R, IN-4] Steve N00003924 5740 Republican 202-225-5037 Methodist IN Steve Stephen Buyer 6.2 http://stevebuyer.house.gov/ C001037 1952-01-09 1530 Longworth House Office Building http://www.house.gov/capuano/contact/email.shtml 8 202-225-9322 Michael 'd':4 '-8':6 'ma':5 'rep':1 'capuano':3,8,10 'michael':2,7,9 M 400063 Capuano Michael_E._Capuano E. Rep. Michael Capuano [D, MA-8] N00000267 6723 Democrat 202-225-5111 Roman Catholic MA Mike Michael Capuano 3.63636363636364 http://www.house.gov/capuano/ C001065 1959-03-02 416 Cannon House Office Building http://www.carney.house.gov/contact.shtml#email 10 202-225-9594 Christopher 'd':4 'pa':5 '-10':6 'rep':1 'carney':3,8,10 'christoph':2,7,9 M 412234 Carney Chris_Carney P. Rep. Christopher Carney [D, PA-10] N00027703 6669 Democrat 202-225-3731 PA Chris Christopher Carney 3.9 http://carney.house.gov/ C001072 1974-10-16 2455 Rayburn House Office Building http://carson.house.gov/contact.me.shtml 7 202-225-5633 André 'd':4 '-7':6 'rep':1 'andr':9 'andré':2,7 'carson':3,8,10 M 412258 Carson Rep. André Carson [D, IN-7] N00029513 4094 Democrat 202-225-4011 IN Andre Carson 2.76 http://carson.house.gov/ D000598 1944-04-13 1526 Longworth House Office Building http://www.house.gov/susandavis/contact.shtml 53 202-225-2948 Susan 'd':4 'ca':5 '-53':6 'rep':1 'davi':3,8,10 'susan':2,7,9 F 400097 Davis Susan_A._Davis A. Rep. Susan Davis [D, CA-53] N00009604 7181 Democrat 202-225-2040 Jewish CA Susan Davis 2.45454545454545 http://www.house.gov/susandavis/ D000210 1941-07-18 2454 Rayburn House Office Building http://www.house.gov/writerep 10 202-225-5658 William 'd':4 'ma':5 '-10':6 'rep':1 'bill':9 'william':2,7,10 'delahunt':3,8,11 M 400102 Delahunt William_D._Delahunt D. Rep. William Delahunt [D, MA-10] Bill N00000280 7716 Democrat 202-225-3111 Catholic MA Bill William Delahunt 2.88888888888889 http://www.house.gov/delahunt/ repdelahunt D000604 1960-05-24 116 Cannon House Office Building http://dent.house.gov/verifyemail.shtml 15 202-226-0778 Charles 'r':4 'pa':5 '-15':6 'rep':1 'dent':3,8,10 'charl':2,7,9 M 400648 Dent Charles_W._Dent Wieder Rep. Charles Dent [R, PA-15] N00026171 6380 Republican 202-225-6411 PA Charles Dent 6.33333333333333 http://dent.house.gov/ D000607 1218 Longworth House Office Building http://donnelly.house.gov/issue_subscribe.shtml 2 202-225-6798 Joe 'd':4 '-2':6 'joe':2,7,9 'rep':1 'donnelli':3,8,10 M 412205 Donnelly Joe_Donnelly Rep. Joe Donnelly [D, IN-2] N00026586 6555 Democrat 202-225-3915 IN Joe Donnelly 5.77777777777778 http://donnelly.house.gov/ E000289 513 Cannon House Office Building http://www.ellsworth.house.gov/index.php?option=com_content&task=view&id=325&Itemid= 8 202-225-3284 Brad 'd':4 '-8':6 'rep':1 'brad':2,7,9 'ellsworth':3,8,10 M 412206 Ellsworth Brad_Ellsworth Rep. Brad Ellsworth [D, IN-8] N00027575 6357 Democrat 202-225-4636 IN Brad Ellsworth 5.0 http://ellsworth.house.gov/ RepBradEllsworth F000043 1956-11-21 2301 Rayburn House Office Building http://fattah.house.gov/?sectionid=8&sectiontree=8 2 202-225-5392 Chaka 'd':4 '-2':6 'pa':5 'rep':1 'chaka':2,7,9 'fattah':3,8,10 M 400130 Fattah Chaka_Fattah Rep. Chaka Fattah [D, PA-2] N00001746 6269 Democrat 202-225-4001 Baptist PA Chaka Fattah 3.0 http://www.house.gov/fattah/ F000443 1970-06-22 Michael 'mike':5 'michael':1,3,6 'ferguson':2,4,7 M 400132 Ferguson Mike_Ferguson Michael Ferguson Mike N00000766 4747 Republican Michael Ferguson G000549 1955-02-25 308 Cannon House Office Building http://www.house.gov/writerep 6 202-225-8440 Jim 'r':4 '-6':6 'pa':5 'jim':2,7,9 'rep':1 'gerlach':3,8,10 M 400147 Gerlach Jim_Gerlach Rep. Jim Gerlach [R, PA-6] N00025025 6597 Republican 202-225-4315 Protestant PA Jim Gerlach 5.85714285714286 http://gerlach.house.gov/ H000528 1945-05-20 2268 Rayburn House Office Building http://www.house.gov/herger/contact.shtml 2 202-225-1740 Walter 'r':4 '-2':6 'ca':5 'rep':1 'walli':9 'herger':3,8,11 'walter':2,7,10 M 400176 Herger Wally_Herger Rep. Walter Herger [R, CA-2] Wally N00007584 6214 Republican 202-225-3076 Latter Day Saints CA Wally Walter Herger 5.375 http://www.house.gov/herger/ RepWallyHerger H001030 1953-06-23 223 Cannon House Office Building http://baronhill.house.gov/IMA/issue_subscribe.shtml 9 202-226-6866 Baron 'd':4 '-9':6 'rep':1 'hill':3,8,10 'baron':2,7,9 M 400177 Hill Baron_Hill P. Rep. Baron Hill [D, IN-9] N00003875 7183 Democrat 202-225-5315 Christian IN Baron Hill 3.66666666666667 http://baronhill.house.gov/ CongressmanBaronHill H000712 1957-03-05 2417 Rayburn House Office Building http://www.holden.house.gov/contactform_zipcheck.shtml 17 202-226-0996 Tim 'd':4 'pa':5 '-17':6 'rep':1 'tim':2,7,9 'holden':3,8,10 M 400183 Holden Tim_Holden Rep. Tim Holden [D, PA-17] N00001469 6306 Democrat 202-225-5546 Roman Catholic PA Tim Holden 4.5 http://www.holden.house.gov/ H001032 1948-10-15 1019 Longworth House Office Building http://www.holt.house.gov/contact.shtml 12 202-225-6025 Rush 'd':4 'nj':5 '-12':6 'rep':1 'holt':3,8,10 'rush':2,7,9 M 400184 Holt Rush_D._Holt Dew Rep. Rush Holt [D, NJ-12] N00000860 7205 Democrat 202-225-5801 Protestant NJ Rush Holt http://www.holt.house.gov RushHolt H001034 1941-06-27 1713 Longworth House Office Building http://honda.house.gov/contactmike.shtml 15 202-225-2699 Michael 'd':4 'ca':5 '-15':6 'rep':1 'mike':9 'honda':3,8,11 'michael':2,7,10 M 400185 Honda Michael_M._Honda M. Rep. Michael Honda [D, CA-15] Mike N00012611 6306 Democrat 202-225-2631 Protestant CA Mike Michael Honda 3.7 http://honda.house.gov/ robpierson L000397 1947-12-21 102 Cannon House Office Building http://lofgren.house.gov/emailform.shtml 16 202-225-3336 Zoe 'd':4 'ca':5 '-16':6 'rep':1 'zoe':2,7,9 'lofgren':3,8,10 F 400245 Lofgren Zoe_Lofgren Rep. Zoe Lofgren [D, CA-16] N00007479 8177 Democrat 202-225-3072 Lutheran CA Zoe Lofgren 5.5 http://lofgren.house.gov/ L000562 1955-03-31 221 Cannon House Office Building http://www.house.gov/writerep 9 202-225-3984 Stephen 'd':4 '-9':6 'ma':5 'rep':1 'lynch':3,8,10 'stephen':2,7,9 M 400249 Lynch Stephen_F._Lynch F. Rep. Stephen Lynch [D, MA-9] N00013855 6143 Democrat 202-225-8273 MA Stephen Lynch 1.14285714285714 http://www.house.gov/lynch/ M001165 1965-01-26 1523 Longworth House Office Building http://kevinmccarthy.house.gov/showpage.asp?ID=69 22 202-225-2908 Kevin 'r':4 'ca':5 '-22':6 'rep':1 'kevin':2,7,9 'mccarthi':3,8,10 M 412190 McCarthy Kevin_McCarthy Rep. Kevin McCarthy [R, CA-22] N00028152 5576 Republican 202-225-2915 CA Kevin McCarthy 7.42857142857143 http://kevinmccarthy.house.gov/ RepKevinMcCarthy M000312 1959-11-20 438 Cannon House Office Building http://www.house.gov/writerep 3 202-225-5759 James 'd':4 '-3':6 'ma':5 'jim':9 'rep':1 'jame':2,7,10 'mcgovern':3,8,11 M 400263 McGovern James_P._McGovern P. Rep. James McGovern [D, MA-3] Jim N00000179 8803 Democrat 202-225-6101 Catholic MA Jim James McGovern 5.0 http://www.house.gov/mcgovern M001168 1973-10-19 1007 Longworth House Office Building http://www.house.gov/formpatrickmurphy/zipauth.shtml 8 202-225-9511 Patrick 'd':4 '-8':6 'pa':5 'rep':1 'murphi':3,8,10 'patrick':2,7,9 M 412233 Murphy Patrick_Murphy J. Rep. Patrick Murphy [D, PA-8] N00027594 6544 Democrat 202-225-4276 PA Patrick Murphy http://patrickmurphy.house.gov/ M001151 1952-09-11 322 Cannon House Office Building http://murphy.house.gov/Contact/zipauth.htm 18 202-225-1844 Tim 'r':4 'pa':5 '-18':6 'rep':1 'tim':2,7,9 'murphi':3,8,10 M 400285 Murphy Tim_Murphy Rep. Tim Murphy [R, PA-18] N00024992 6710 Republican 202-225-2301 Roman Catholic PA Tim Murphy 4.92307692307692 http://murphy.house.gov/ N000015 1949-02-14 2208 Rayburn House Office Building http://www.house.gov/neal/write_neal.html 2 202-225-8112 Richard 'd':4 '-2':6 'ma':5 'rep':1 'neal':3,8,10 'richard':2,7,9 M 400291 Neal Richard_E._Neal E. Rep. Richard Neal [D, MA-2] N00000153 6215 Democrat 202-225-5601 Roman Catholic MA Richard Neal 2.22222222222222 http://www.house.gov/neal/ N000181 1973-10-01 1013 Longworth House Office Building http://www.nunes.house.gov/index.cfm?FuseAction=ContactUs.ContactForm 21 202-225-3404 Devin 'r':4 'ca':5 '-21':6 'rep':1 'nune':3,8,10 'devin':2,7,9 M 400297 Nunes Devin_Nunes G. Rep. Devin Nunes [R, CA-21] N00007248 6373 Republican 202-225-2523 Roman Catholic CA Devin Nunes http://www.house.gov/nunes/ RepDevinNunes P000096 1937-01-25 2464 Rayburn House Office Building http://pascrell.house.gov/contact/ 8 202-225-5782 William 'd':4 '-8':6 'nj':5 'rep':1 'bill':9 'pascrel':3,8,11 'william':2,7,10 M 400309 Pascrell Bill_Jr.Pascrell J. Rep. William Pascrell [D, NJ-8] Bill N00000751 5646 Democrat 202-225-5751 Catholic NJ Bill William Pascrell 0.5 http://www.pascrell.house.gov/ P000587 1959-06-07 1317 Longworth House Office Building https://forms.house.gov/pence/IMA/contact_form.htm 6 202-225-3382 Mike 'r':4 '-6':6 'rep':1 'mike':2,7,9 'penc':3,8,10 M 400315 Pence Mike_Pence Rep. Mike Pence [R, IN-6] N00003765 7751 Republican 202-225-3021 Christian IN Mike Pence 6.0 http://mikepence.house.gov/ CongressmanMikePence P000265 1940-05-28 2462 Rayburn House Office Building https://forms.house.gov/petri/zip_authen.shtml 6 202-225-2356 Thomas 'r':4 '-6':6 'wi':5 'rep':1 'tom':9 'petri':3,8,11 'thoma':2,7,10 M 400318 Petri Thomas_E._Petri E. Rep. Thomas Petri [R, WI-6] Tom N00004426 5375 Republican 202-225-2476 Lutheran WI Tom Thomas Petri 4.28571428571429 http://www.house.gov/petri/ P000373 1939-10-10 420 Cannon House Office Building http://www.house.gov/pitts/contact.shtml 16 202-225-2013 Joseph 'r':4 'pa':5 '-16':6 'rep':1 'pitt':3,8,10 'joseph':2,7,9 M 400320 Pitts Joseph_R._Pitts R. Rep. Joseph Pitts [R, PA-16] N00001633 5337 Republican 202-225-2411 Protestant PA Joe Joseph Pitts 3.58333333333333 http://www.house.gov/pitts/ P000523 1940-08-17 2162 Rayburn House Office Building http://price.house.gov/contact/contact_form.shtml 4 202-225-2014 David 'd':4 '-4':6 'nc':5 'rep':1 'david':2,7,9 'price':3,8,10 M 400326 Price David_E._Price Eugene Rep. David Price [D, NC-4] N00002260 7879 Democrat 202-225-1784 Baptist NC David Price 3.6 http://price.house.gov/ repdavidprice R000572 1963-06-02 133 Cannon House Office Building http://www.mikerogers.house.gov/Contact.aspx 8 202-225-5820 Michael 'r':4 '-8':6 'mi':5 'rep':1 'mike':9 'roger':3,8,11 'michael':2,7,10 M 400342 Rogers Mike_Rogers Rep. Michael Rogers [R, MI-8] Mike N00009668 6351 Republican 202-225-4872 MI Michael Rogers 5.9 http://www.mikerogers.house.gov/ RepMikeRogers S000030 1960-01-07 1230 Longworth House Office Building http://www.lorettasanchez.house.gov/index.php?option=com_content&task=view&id=218&Itemid=17 47 202-225-5859 Loretta 'd':4 'ca':5 '-47':6 'rep':1 'loretta':2,7,9 'sanchez':3,8,10 F 400356 Sanchez Loretta_Sanchez B. Rep. Loretta Sanchez [D, CA-47] N00008274 6787 Democrat 202-225-2965 Roman Catholic CA Loretta Sanchez 0.333333333333333 http://www.lorettasanchez.house.gov S000364 1958-02-21 2452 Rayburn House Office Building http://www.house.gov/shimkus/emailme.shtml 19 202-225-5880 John 'r':4 'il':5 '-19':6 'rep':1 'john':2,7,9 'shimkus':3,8,10 M 400373 Shimkus John_Shimkus M. Rep. John Shimkus [R, IL-19] N00004961 5720 Republican 202-225-5271 Lutheran IL John Shimkus 4.875 http://www.house.gov/shimkus/ S001143 1950-07-18 2231 Rayburn House Office Building http://souder.house.gov/index.cfm?FuseAction=Contact.ContactForm 3 202-225-3479 Mark 'r':4 '-3':6 'rep':1 'mark':2,7,9 'souder':3,8,10 M 400385 Souder Mark_E._Souder Edward Rep. Mark Souder [R, IN-3] N00003844 6372 Republican 202-225-4436 United Brethren in Christ IN Mark Souder 4.25 http://souder.house.gov/ S000822 1941-04-16 2370 Rayburn House Office Building http://www.house.gov/writerep 6 202-225-3973 Clifford 'r':4 '-6':6 'fl':5 'rep':1 'cliff':9 'stearn':3,8,11 'clifford':2,7,10 M 400388 Stearns Cliff_Stearns B. Rep. Clifford Stearns [R, FL-6] Cliff N00002782 5430 Republican 202-225-5744 Presbyterian FL Cliff Clifford Stearns 5.0 http://www.house.gov/stearns/ T000460 1951-01-24 231 Cannon House Office Building http://mikethompson.house.gov/contact/email.shtml 1 202-225-4335 C. 'c':2,7,10 'd':4 '-1':6 'ca':5 'rep':1 'mike':9 'thompson':3,8,11 M 400403 Thompson Mike_Thompson Rep. C. Thompson [D, CA-1] Mike N00007419 6775 Democrat 202-225-3311 Catholic CA Mike C. Thompson 1.875 http://mikethompson.house.gov U000031 1953-04-23 2183 Rayburn House Office Building http://www.house.gov/writerep 6 202-225-4986 Frederick 'r':4 '-6':6 'mi':5 'rep':1 'fred':9 'upton':3,8,11 'frederick':2,7,10 M 400414 Upton Fred_Upton Stephen Rep. Frederick Upton [R, MI-6] Fred N00004133 5094 Republican 202-225-3761 Protestant MI Fred Frederick Upton 5.16666666666667 http://www.house.gov/upton/ W000099 1947-06-19 James 'jim':5 'jame':1,3,6 'walsh':2,4,7 M 400420 Walsh James_T._Walsh T. James Walsh Jim N00001261 4634 Republican Roman Catholic James Walsh W000784 1951-09-10 Albert 'wynn':2,4,6 'albert':1,3,5 M 400438 Wynn Albert_Russell_Wynn Russell Albert Wynn N00001849 4629 Democrat Baptist Albert Wynn action 49688 1208145600 Mon Apr 14 00:00:00 -0500 2008 165027 Referred to the Subcommittee on Courts, the Internet, and Intellectual Property. action 49688 1205380800 Thu Mar 13 00:00:00 -0500 2008 147700 Sponsor introductory remarks on measure. (CR E401-402) introduced 49688 1205380800 Thu Mar 13 00:00:00 -0500 2008 147699 action 49688 1205380800 Thu Mar 13 00:00:00 -0500 2008 147702 Referred to House Energy and Commerce action 49688 1205380800 Thu Mar 13 00:00:00 -0500 2008 154053 Referred to the Subcommittee on Health. action 49688 1205380800 Thu Mar 13 00:00:00 -0500 2008 147703 Referred to House Judiciary action 49688 1205380800 Thu Mar 13 00:00:00 -0500 2008 147701 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.