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 2016_register executive 2016-12-29 article Notices D09002ee1c7f3060d D09002ee1c7f306c5 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 or Agency) is announcing the availability of a guidance for industry entitled "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product." This guidance is to assist the pharmaceutical industry and other investigators engaged in biosimilar product development in determining the clinical pharmacology data necessary for evaluation of a proposed biosimilar product. This guidance finalizes the draft guidance with the same name issued in May 2014. This guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). 81 FR 96010 https://www.govinfo.gov/app/details/FR-2016-12-29/2016-31511 2016-31511 fr29de16-75 4164-01-P Docket No. FDA-2014-D-0234 https://www.govinfo.gov/app/details/FR-2016-12-29/2016-31511 https://www.govinfo.gov/content/pkg/FR-2016-12-29/html/2016-31511.htm https://www.govinfo.gov/content/pkg/FR-2016-12-29/pdf/2016-31511.pdf 2 p. 96010 96011 81 FR 96010 Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Guidance for Industry; Availability; Federal Register Vol. 81, Issue NOTICE 2016-31511 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2014-D-0234 4164-01-P 2016-31511 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product." This guidance is to assist the pharmaceutical industry and other investigators engaged in biosimilar product development in determining the clinical pharmacology data necessary for evaluation of a proposed biosimilar product. This guidance finalizes the draft guidance with the same name issued in May 2014. This guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

Submit either electronic or written comments on Agency guidances at any time. 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- 796-2500; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Guidance: Clinical Pharmacology Data to Support Demonstration of Biosimilarity to Reference Product , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 81, no. 250 Office of the Federal Register, National Archives and Records Administration 2016-12-29 continuing daily deposited born digital 487 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-12-29 P0b002ee1932b24d5 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr29de16 https://www.govinfo.gov/app/details/FR-2016-12-29 https://www.govinfo.gov/content/pkg/FR-2016-12-29/pdf/FR-2016-12-29.pdf https://www.govinfo.gov/content/pkg/FR-2016-12-29/xml/FR-2016-12-29.xml fdlp 95853 96328 DGPO 2016-12-29 2024-06-01 FR-2016-12-29 machine generated eng FR FR-2016-12-29 81 250