{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft strategy document titled \"BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document\" (Strategy Document). This draft Strategy Document is intended to summarize the discussion that occurred at the FDA public workshop, \"Advancing the Development of Interchangeable Products: Identifying Future Needs,\" held on September 19, 2025, and to describe FDA's future directions to support interchangeable biosimilar products. FDA is issuing this draft Strategy Document to fulfill a commitment FDA made in the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 through 2027 (BsUFA III) to publish a post-workshop draft strategy document for public comment.","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/2026/09/18/2026-19166.html","cfr_references":[],"citation":"91 FR 59140","comment_url":"http://www.regulations.gov/commenton/FDA-2025-N-2787-0007","comments_close_on":"2026-11-17","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this draft Strategy Document by November 17, 2026 to ensure that the Agency considers your comment on this draft Strategy Document before it begins work on the final version of the Strategy Document.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-2787"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-09-18","updated_at":"2026-09-18T10:56:50.318-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-2787-0007","allow_late_comments":false,"id":"FDA-2025-N-2787-0007","comment_end_date":"2026-11-18","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA-2025-N-2787","title":"Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments"}],"document_number":"2026-19166","effective_on":null,"end_page":59141,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/09/18/2026-19166.xml","html_url":"https://www.federalregister.gov/documents/2026/09/18/2026-19166/biosimilar-user-fee-act-iii-future-needs-in-the-development-of-interchangeable-products","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-19166?publication_date=2026-09-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-09-18/2026-19166/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":797,"last_updated":"2026-10-25 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-18/pdf/2026-19166.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-19166.pdf?1789649120","publication_date":"2026-09-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/09/18/2026-19166.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-2025-N-2787","supporting_documents_count":0,"docket_id":"FDA-2025-N-2787","document_id":"FDA-2025-N-2787-0007","regulation_id_number":null,"title":"Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments","checked_regulationsdotgov_at":"2026-09-19T17:55:06Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2025-N-2787-0007","significant":null,"signing_date":null,"start_page":59140,"subtype":null,"title":"Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document","toc_doc":"Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document","toc_subject":null,"topics":[],"type":"Notice","volume":91}