{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2026. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA III directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year.","action":"Notice.","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/2025/07/30/2025-14416.html","cfr_references":[],"citation":"90 FR 35872","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"These fees apply to the period from October 1, 2025, through September 30, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-2273"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-07-30","updated_at":"2025-07-30T10:56:48.580-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-2273-0001","allow_late_comments":false,"id":"FDA-2025-N-2273-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-N-2273","title":"Biosimilar User Fee Rates for Fiscal Year 2026"}],"document_number":"2025-14416","effective_on":null,"end_page":35876,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/07/30/2025-14416.xml","html_url":"https://www.federalregister.gov/documents/2025/07/30/2025-14416/biosimilar-user-fee-rates-for-fiscal-year-2026","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-14416?publication_date=2025-07-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-07-30/2025-14416/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":1353,"last_updated":"2026-08-25 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-30/pdf/2025-14416.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-14416.pdf?1753793115","publication_date":"2025-07-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/07/30/2025-14416.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-2273","supporting_documents_count":0,"docket_id":"FDA-2025-N-2273","document_id":"FDA-2025-N-2273-0001","regulation_id_number":null,"title":"Biosimilar User Fee Rates for Fiscal Year 2026","checked_regulationsdotgov_at":"2025-07-31T17:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":35872,"subtype":null,"title":"Biosimilar User Fee Rates for Fiscal Year 2026","toc_doc":"Biosimilar User Fee Rates for Fiscal Year 2026","toc_subject":null,"topics":[],"type":"Notice","volume":90}