s 44856 1182830400 false 1227070800 1695 958 110 300059

6/26/2007--Introduced.<br/>Biologics Price Competition and Innovation Act of 2007 - 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 license the biological product if it is biosimilar to or interchangeable with the reference product. Allows a determination of interchangeability if the product is: (1) biosimilar to the reference product and can be expected to produce the same clinical result in any given patient; and (2) the risk in terms of safety or diminished efficacy of alternating or switching between the products is not greater than the risk of using the reference product without switching.<br/>Prohibits the Secretary from determining that a second or subsequent biological product is interchangeable for any condition of use until one year after the first commercial marketing of the first product to be approved as interchangeable for that reference product.<br/>Prohibits the Secretary from making approval of an application under this Act f effective until 12 years after the date on which the reference product was first licensed.<br/>Authorizes the Secretary to issue product class-specific guidance.<br/>Sets forth provisions governing patent infringement actions related to the exchange of confidential information, good faith negotiations, and the filing of an infringement action.<br/>Requires the Secretary to: (1) develop recommendations with respect to the goals for the process for the review of biosimilar biological product applications; and (2) collect and evaluate data regarding the cost of reviewing such applications.<br/>

1227070800 2008-11-19 Tue Dec 09 11:01:52 -0600 2008 introduced 44856 'act':6 '2007':8 'innov':5 'price':2 'biolog':1 'competit':3 51141 short introduced 44856 'act':9 'bill':2 'life':26 'amend':4 'innov':23 'biolog':19 'health':7 'promot':22 'public':6 'purpos':31 'scienc':27 'servic':8 'pathway':13 'product':20 'licensur':16 'establish':11 'biosimilar':18 47962 official action 44856 1227070800 Wed Nov 19 00:00:00 -0600 2008 178662 Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute. Without written report. K000105 1932-02-22 317 Russell Senate Office Building http://kennedy.senate.gov/senator/contact.cfm 202-224-2417 Edward 'd':4 'ma':5 'sen':1 'ted':8 'edward':2,6,9 'kennedi':3,7,10 M 300059 Kennedy Edward_Kennedy M. Sen. Edward Kennedy [D, MA] Ted N00000308 19398 Democrat 202-224-4543 Catholic MA Ted Edward Kennedy 3.58715596330275 http://kennedy.senate.gov/ C001041 1947-10-26 Hillary 'd':4 'ny':5 'sen':1 'clinton':3,7,9 'hillari':2,6,8 F 300022 Clinton Hillary_Clinton Rodham Sen. Hillary Clinton [D, NY] N00000019 25217 Democrat Methodist NY Hillary Clinton 3.37404580152672 E000285 1944-02-01 379a Russell Senate Office Building http://enzi.senate.gov/public/index.cfm?FuseAction=ContactInformation.EmailSenatorEnzi 202-228-0359 Michael 'r':4 'wy':5 'sen':1 'enzi':3,7,9 'michael':2,6,8 M 300041 Enzi Michael_Enzi B. Sen. Michael Enzi [R, WY] N00006249 7003 Republican 202-224-3424 Presbyterian WY Mike Michael Enzi 3.22727272727273 http://enzi.senate.gov/public/ SenatorEnzi H000338 1934-03-22 104 Hart Senate Office Building http://hatch.senate.gov/public/index.cfm?FuseAction=Offices.Contact 202-224-6331 Orrin 'r':4 'ut':5 'sen':1 'hatch':3,7,9 'orrin':2,6,8 M 300052 Hatch Orrin_Hatch G. Sen. Orrin Hatch [R, UT] N00009869 9150 Republican 202-224-5251 Latter Day Saints UT Orrin Hatch 2.77083333333333 http://hatch.senate.gov/public/ S000148 1950-11-23 313 Hart Senate Office Building http://schumer.senate.gov/new_website/contact.cfm 202-228-3027 Charles 'd':4 'ny':5 'sen':1 'charl':2,6,8 'schumer':3,7,9 M 300087 Schumer Charles_Schumer E. Sen. Charles Schumer [D, NY] N00001093 20308 Democrat 202-224-6542 Jewish NY Chuck Charles Schumer 2.24468085106383 http://schumer.senate.gov/ senatorschumer action 44856 1227070800 Wed Nov 19 00:00:00 -0600 2008 178662 Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute. Without written report. calendar 44856 1227070800 Wed Nov 19 00:00:00 -0600 2008 178663 Placed on Senate Legislative Calendar under General Orders. Calendar No. 1127. action 44856 1182916800 Wed Jun 27 00:00:00 -0500 2007 120097 Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. calendar 44856 1182916800 Wed Jun 27 00:00:00 -0500 2007 177724 Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. action 44856 1182916800 Wed Jun 27 00:00:00 -0500 2007 143348 Committee on Health, Education, Labor, and Pensions. Date of scheduled consideration. S-211. 11:00 a.m. action 44856 1182830400 Tue Jun 26 00:00:00 -0500 2007 119983 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. introduced 44856 1182830400 Tue Jun 26 00:00:00 -0500 2007 119982