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 2020_register executive 2020-02-07 article Notices D09002ee1c7b8117d D09002ee1c7b811f6 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Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed." When finalized, this draft guidance will provide recommendations to applicants seeking licensure under the Public Health Service Act (the PHS Act) of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product's licensed conditions of use. Additionally, when finalized, this draft guidance will also provide recommendations on the submission of a supplement to a licensed biologics license application (BLA) seeking to add a condition of use that previously has been licensed for the reference product to the labeling of a licensed biosimilar or interchangeable product, including considerations related to the timing of such submissions. 85 FR 7313 https://www.govinfo.gov/app/details/FR-2020-02-07/2020-02421 2020-02421 fr07fe20-58 4164-01-P Docket No. FDA-2019-D-5270 https://www.govinfo.gov/app/details/FR-2020-02-07/2020-02421 https://www.govinfo.gov/content/pkg/FR-2020-02-07/html/2020-02421.htm https://www.govinfo.gov/content/pkg/FR-2020-02-07/pdf/2020-02421.pdf 3 p. 7313 7315 85 FR 7313 Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed; Draft Guidance for Industry; Availability; Federal Register Vol. 85, Issue NOTICE 2020-02421 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2020-04-07 Docket No. FDA-2019-D-5270 4164-01-P 2020-02421 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed." When finalized, this draft guidance will provide recommendations to applicants seeking licensure under the Public Health Service Act (the PHS Act) of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product's licensed conditions of use. Additionally, when finalized, this draft guidance will also provide recommendations on the submission of a supplement to a licensed biologics license application (BLA) seeking to add a condition of use that previously has been licensed for the reference product to the labeling of a licensed biosimilar or interchangeable product, including considerations related to the timing of such submissions.

Submit either electronic or written comments on the draft guidance by April 7, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993-0002, 301- 796-1042; 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: Biosimilars and Interchangeable Biosimilars: Licensure for Fewer than All Conditions of Use for Which the Reference Product Has Been Licensed, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 85, no. 26 Office of the Federal Register, National Archives and Records Administration 2020-02-07 continuing daily deposited born digital 261 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2020-02-07 P0b002ee1a58ea3dd 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr07fe20 https://www.govinfo.gov/app/details/FR-2020-02-07 https://www.govinfo.gov/content/pkg/FR-2020-02-07/pdf/FR-2020-02-07.pdf https://www.govinfo.gov/content/pkg/FR-2020-02-07/xml/FR-2020-02-07.xml fdlp 7191 7442 DGPO 2020-02-07 2024-05-30 FR-2020-02-07 machine generated eng FR FR-2020-02-07 85 26