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 2014-05-14 article Notices D09002ee1c7fa1450 D09002ee1c7fa14d4 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United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product." This guidance is intended to assist sponsors in developing a clinical pharmacology program to support a decision that a proposed therapeutic biological product is biosimilar to, that is not clinically meaningfully different from, its reference product. Specifically, the guidance discusses some of the overarching concepts related to clinical pharmacology studies for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical trials. This draft guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). 79 FR 27622 https://www.govinfo.gov/app/details/FR-2014-05-14/2014-11053 2014-11053 fr14my14-88 4160-01-P Docket No. FDA-2014-D-0234 https://www.govinfo.gov/app/details/FR-2014-05-14/2014-11053 https://www.govinfo.gov/content/pkg/FR-2014-05-14/html/2014-11053.htm https://www.govinfo.gov/content/pkg/FR-2014-05-14/pdf/2014-11053.pdf 2 p. 27622 27623 79 FR 27622 Draft Guidance for Industry on Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Availability; Federal Register Vol. 79, Issue NOTICE 2014-11053 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2014-D-0234 4160-01-P 2014-11053 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product." This guidance is intended to assist sponsors in developing a clinical pharmacology program to support a decision that a proposed therapeutic biological product is biosimilar to, that is not clinically meaningfully different from, its reference product. Specifically, the guidance discusses some of the overarching concepts related to clinical pharmacology studies for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical trials. This draft 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).

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 August 12, 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- 796-2500, email: sandra.benton@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852- 1448, 301-827-6210. Draft Guidance for Industry: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product , sandra.benton@fda.hhs.gov http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 79, no. 93 Office of the Federal Register, National Archives and Records Administration 2014-05-14 continuing daily deposited born digital 260 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-05-14 P0b002ee188e350a8 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr14my14 https://www.govinfo.gov/app/details/FR-2014-05-14 https://www.govinfo.gov/content/pkg/FR-2014-05-14/pdf/FR-2014-05-14.pdf https://www.govinfo.gov/content/pkg/FR-2014-05-14/xml/FR-2014-05-14.xml fdlp 27477 27728 DGPO 2014-05-14 2024-06-02 FR-2014-05-14 machine generated eng FR FR-2014-05-14 79 93