{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.\" This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application under the Public Health Service Act (PHS Act).","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/2025/11/20/2025-20380.html","cfr_references":[],"citation":"90 FR 52410","comment_url":null,"comments_close_on":"2026-01-20","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by January 20, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2011-D-0605"],"dockets":[{"supporting_documents":[{"title":"submission inadvertently submitted to docket FDA-2011-D-0605","document_id":"FDA-2011-D-0605-0053"},{"title":"Merck & Co., Inc. - Comment re FDA-2011-D-0605-0032","document_id":"FDA-2011-D-0605-0033"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-11-20","updated_at":"2025-11-20T11:04:38.732-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2011-D-0605-0059","allow_late_comments":false,"id":"FDA-2011-D-0605-0059","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-2011-D-0605","title":"Scientific Considerations in Demonstrating Biosimilarity to a Reference Product"}],"document_number":"2025-20380","effective_on":null,"end_page":52411,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/11/20/2025-20380.xml","html_url":"https://www.federalregister.gov/documents/2025/11/20/2025-20380/scientific-considerations-in-demonstrating-biosimilarity-to-a-reference-product-updated","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-20380?publication_date=2025-11-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-11-20/2025-20380/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":708,"last_updated":"2026-04-04 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-20/pdf/2025-20380.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20380.pdf?1763559916","publication_date":"2025-11-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/11/20/2025-20380.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"submission inadvertently submitted to docket FDA-2011-D-0605","document_id":"FDA-2011-D-0605-0053"},{"title":"Merck & Co., Inc. - Comment re FDA-2011-D-0605-0032","document_id":"FDA-2011-D-0605-0033"}],"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-2011-D-0605","supporting_documents_count":2,"docket_id":"FDA-2011-D-0605","document_id":"FDA-2011-D-0605-0059","regulation_id_number":null,"title":"Scientific Considerations in Demonstrating Biosimilarity to a Reference Product","checked_regulationsdotgov_at":"2025-11-21T18:55:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52410,"subtype":null,"title":"Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry; Availability","toc_doc":"Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies","toc_subject":"Guidance","topics":[],"type":"Notice","volume":90}