{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.\" When finalized, this draft guidance will provide recommendations to applicants seeking licensure under the Public Health Service Act (the PHS Act) of a proposed biosimilar or proposed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 Additionally, when finalized, this draft guidance will also provide recommendations on the submission of a supplement to a licensed biologics license application (BLA) seeking to add a condition of use that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.","action":"Notice of availability.","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/2020/02/07/2020-02421.html","cfr_references":[],"citation":"85 FR 7313","comment_url":null,"comments_close_on":"2020-04-07","correction_of":null,"corrections":[],"dates":"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either electronic or written comments on the draft guidance by April 7, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-5270"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2020-02-07","updated_at":"2023-02-28T13:47:11.725-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-D-5270-0001","allow_late_comments":null,"id":"FDA-2019-D-5270-0001","comment_end_date":"2020-04-08","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2019-D-5270","title":"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"}],"document_number":"2020-02421","effective_on":null,"end_page":7315,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/02/07/2020-02421.xml","html_url":"https://www.federalregister.gov/documents/2020/02/07/2020-02421/biosimilars-and-interchangeable-biosimilars-licensure-for-fewer-than-all-conditions-of-use-for-which","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-02421?publication_date=2020-02-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-02-07/2020-02421/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1198,"last_updated":"2026-08-24 00:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-02-07/pdf/2020-02421.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-02421.pdf?1580996719","publication_date":"2020-02-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/02/07/2020-02421.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2019-D-5270","supporting_documents_count":0,"docket_id":"FDA-2019-D-5270","document_id":"FDA-2019-D-5270-0001","regulation_id_number":null,"title":"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","checked_regulationsdotgov_at":"2023-02-28T18:47:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":7313,"subtype":null,"title":"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","toc_doc":"Biosimilars and Interchangeable Biosimilars:  Licensure for Fewer than All Conditions of Use for Which the Reference Product Has Been Licensed","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":85}