United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2014_register executive 2014-10-07 article Notices D09002ee1c7f8f29e D09002ee1c7f8f329 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act." This draft guidance is intended to assist sponsors developing biological products, sponsors holding biologics license applications (BLAs), and other interested parties in providing information and data that will help the Agency determine the date of first licensure for a reference product under 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. 79 FR 45448 https://www.govinfo.gov/app/details/FR-2014-08-05/2014-18169 2014-18169 fr05au14-66 4164-01-P Docket No. FDA-2013-D-1165 https://www.govinfo.gov/app/details/FR-2014-08-05/2014-18169 https://www.govinfo.gov/content/pkg/FR-2014-08-05/html/2014-18169.htm https://www.govinfo.gov/content/pkg/FR-2014-08-05/pdf/2014-18169.pdf 3 p. 45448 45450 79 FR 45448 Draft Guidance for Industry on Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act; Availability; Federal Register Vol. 79, Issue NOTICE 2014-18169 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2013-D-1165 4164-01-P 2014-18169 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act." This draft guidance is intended to assist sponsors developing biological products, sponsors holding biologics license applications (BLAs), and other interested parties in providing information and data that will help the Agency determine the date of first licensure for a reference product under 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 6, 2014. Submit either electronic or written comments concerning the proposed collection of information by October 6, 2014. Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1042; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Guidance: Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act; Availability , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 79, no. 150 Office of the Federal Register, National Archives and Records Administration 2014-08-05 continuing daily deposited born digital 368 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-08-05 P0b002ee189da16c3 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr05au14 https://www.govinfo.gov/app/details/FR-2014-08-05 https://www.govinfo.gov/content/pkg/FR-2014-08-05/pdf/FR-2014-08-05.pdf https://www.govinfo.gov/content/pkg/FR-2014-08-05/xml/FR-2014-08-05.xml fdlp 45309 45669 DGPO 2014-10-07 2024-06-02 FR-2014-08-05 machine generated eng FR FR-2014-08-05 79 150