{"abstract":"The Food and Drug Administration (FDA) is proposing a regulation to designate official names and proper names for certain biological products. These products are filgrastim-sndz (Biologics License Application (BLA) 125553), filgrastim (BLA 103353), tbo- filgrastim (BLA 125294), pegfilgrastim (BLA 125031), epoetin alfa (BLA 103234), and infliximab (BLA 103772). The official names and proper names of these products would include distinguishing suffixes composed of four lowercase letters and would be designated as filgrastim-bflm (BLA 125553), filgrastim-jcwp (BLA 103353), filgrastim-vkzt (BLA 125294), pegfilgrastim-ljfd (BLA 125031), epoetin alfa-cgkn (BLA 103234), and infliximab-hjmt (BLA 103772). Although FDA is continuing to consider the appropriate naming convention for biological products, including how such a convention would be applied retrospectively to currently licensed products, FDA is proposing to take action with respect to these six products because of the need to encourage routine usage of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices for the biological products subject to this rulemaking, and to avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2015/08/28/2015-21382.html","cfr_references":[{"chapter":null,"citation_url":null,"part":299,"title":21}],"citation":"80 FR 52224","comment_url":null,"comments_close_on":"2015-11-12","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the proposed rule by November 12, 2015. See section IV of this document for the proposed effective date of any final rule that may publish based on this proposal.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-0648"],"dockets":[{"supporting_documents":[{"title":"Attachment 1 Comment from U.S. Pharmacopeial Convention Dated October 26, 2015 re Comment from U.S. Pharmacopeil Convention Dated November 12, 2015","document_id":"FDA-2015-N-0648-0071"},{"title":"Reference 02- Influence of the HLA-DRB1 Genotype on Antibody Development to Interferon Beta in Multiple Sclerosis re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0015"},{"title":"Reference 03- 2010 Specialty Drug Trend Report re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0014"},{"title":"Reference 04- Evaluation of Medical Specialty Medications  Utilization and Management Opportunities re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0013"},{"title":"Reference 05- Postmarketing Spontaneous Pharmacovigilance Reporting Systems, Chapter 10, in Pharmacoepidemiology, 5th ed re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0012"},{"title":"Reference 06- Evaluating the Completeness and Accuracy of MedWatch Data re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0011"},{"title":"Reference 07- ASHP Guidelines on Preventing Medication Errors With Chemotherapy and Biotherapy re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0010"},{"title":"Reference 08 - StandardOrderSets re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0009"},{"title":"Reference 09- Comments from AARP to the Draft Guidance Documents on Biosimilar Product Development re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0008"},{"title":"Reference 10- Apotex Announces FDA Has Accepted for Filing Its Biosimilar Application for Pegfilgrastim re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0007"}],"agency_name":null,"documents":[{"comment_count":56,"comment_start_date":"2015-08-28","updated_at":"2023-02-28T23:58:25.769-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-N-0648-0001","allow_late_comments":null,"id":"FDA-2015-N-0648-0001","comment_end_date":"2015-11-13","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":15,"id":"FDA-2015-N-0648","title":"Designation of Official Names and Proper Names for Certain Biological Products"}],"document_number":"2015-21382","effective_on":null,"end_page":52231,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/08/28/2015-21382.xml","html_url":"https://www.federalregister.gov/documents/2015/08/28/2015-21382/designation-of-official-names-and-proper-names-for-certain-biological-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-21382?publication_date=2015-08-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-08-28/2015-21382/mods.xml","not_received_for_publication":null,"page_length":8,"page_views":{"count":7239,"last_updated":"2026-06-24 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-08-28/pdf/2015-21382.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-21382.pdf?1440679626","publication_date":"2015-08-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/08/28/2015-21382.txt","regulation_id_number_info":{"0910-AH25":null},"regulation_id_numbers":["0910-AH25"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 1 Comment from U.S. Pharmacopeial Convention Dated October 26, 2015 re Comment from U.S. Pharmacopeil Convention Dated November 12, 2015","document_id":"FDA-2015-N-0648-0071"},{"title":"Reference 02- Influence of the HLA-DRB1 Genotype on Antibody Development to Interferon Beta in Multiple Sclerosis re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0015"},{"title":"Reference 03- 2010 Specialty Drug Trend Report re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0014"},{"title":"Reference 04- Evaluation of Medical Specialty Medications  Utilization and Management Opportunities re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0013"},{"title":"Reference 05- Postmarketing Spontaneous Pharmacovigilance Reporting Systems, Chapter 10, in Pharmacoepidemiology, 5th ed re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0012"},{"title":"Reference 06- Evaluating the Completeness and Accuracy of MedWatch Data re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0011"},{"title":"Reference 07- ASHP Guidelines on Preventing Medication Errors With Chemotherapy and Biotherapy re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0010"},{"title":"Reference 08 - StandardOrderSets re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0009"},{"title":"Reference 09- Comments from AARP to the Draft Guidance Documents on Biosimilar Product Development re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0008"},{"title":"Reference 10- Apotex Announces FDA Has Accepted for Filing Its Biosimilar Application for Pegfilgrastim re Designation of Official Names and Proper Names for Certain Biological Products","document_id":"FDA-2015-N-0648-0007"}],"comments_count":56,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-0648","supporting_documents_count":15,"docket_id":"FDA-2015-N-0648","document_id":"FDA-2015-N-0648-0001","regulation_id_number":"0910-AH25","title":"Designation of Official Names and Proper Names for Certain Biological Products","checked_regulationsdotgov_at":"2023-03-01T04:58:24Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52224,"subtype":null,"title":"Designation of Official Names and Proper Names for Certain Biological Products","toc_doc":"Designation of Official Names and Proper Names for Certain Biological Products","toc_subject":null,"topics":["Drugs"],"type":"Proposed Rule","volume":80}