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 2015_register executive 2015-08-28 article Notices D09002ee1c7f73096 D09002ee1c7f73116 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Agency or Subagency The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled "Nonproprietary Naming of Biological Products." The draft guidance describes our current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix. Our current thinking is that shared nonproprietary names are not appropriate for all biological products. There is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable. Accordingly, for biological products, we intend to designate a nonproprietary name that includes a suffix composed of four lowercase letters. Each suffix will be incorporated in the nonproprietary name of the product. This naming convention is applicable to biological products previously licensed and newly licensed under the PHS Act. The nonproprietary name designated for originator biological products, related biological products, and biosimilars will include a unique suffix. However, FDA is considering whether the nonproprietary name for an interchangeable product should include a unique suffix, or should share the same suffix as its reference product. FDA invites comment on the draft guidance and solicits comments on ways to improve active pharmacovigilance systems for the purposes of monitoring the safety of biological products. 80 FR 52296 https://www.govinfo.gov/app/details/FR-2015-08-28/2015-21383 2015-21383 fr28au15-68 4164-01-P Docket No. FDA-2013-D-1543 https://www.govinfo.gov/app/details/FR-2015-08-28/2015-21383 https://www.govinfo.gov/content/pkg/FR-2015-08-28/html/2015-21383.htm https://www.govinfo.gov/content/pkg/FR-2015-08-28/pdf/2015-21383.pdf 4 p. 52296 52299 80 FR 52296 Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability; Federal Register Vol. 80, Issue NOTICE 2015-21383 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2013-D-1543 4164-01-P 2015-21383 Notice.

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a draft guidance for industry entitled "Nonproprietary Naming of Biological Products." The draft guidance describes our current thinking on the need for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix. Our current thinking is that shared nonproprietary names are not appropriate for all biological products. There is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable. Accordingly, for biological products, we intend to designate a nonproprietary name that includes a suffix composed of four lowercase letters. Each suffix will be incorporated in the nonproprietary name of the product. This naming convention is applicable to biological products previously licensed and newly licensed under the PHS Act. The nonproprietary name designated for originator biological products, related biological products, and biosimilars will include a unique suffix. However, FDA is considering whether the nonproprietary name for an interchangeable product should include a unique suffix, or should share the same suffix as its reference product. FDA invites comment on the draft guidance and solicits comments on ways to improve active pharmacovigilance systems for the purposes of monitoring the safety of biological products.

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, including responses to the questions in this notice, by October 27, 2015. Submit either electronic or written comments on the collection of information by October 27, 2015. 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, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Guidance: Nonproprietary Naming of Biological Products , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 80, no. 167 Office of the Federal Register, National Archives and Records Administration 2015-08-28 continuing daily deposited born digital 212 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-08-28 P0b002ee18d687b05 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28au15 https://www.govinfo.gov/app/details/FR-2015-08-28 https://www.govinfo.gov/content/pkg/FR-2015-08-28/pdf/FR-2015-08-28.pdf https://www.govinfo.gov/content/pkg/FR-2015-08-28/xml/FR-2015-08-28.xml fdlp 52173 52373 DGPO 2015-08-28 2024-06-02 FR-2015-08-28 machine generated eng FR FR-2015-08-28 80 167