{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.\" This guidance is to assist the pharmaceutical industry and other investigators engaged in biosimilar product development in determining the clinical pharmacology data necessary for evaluation of a proposed biosimilar product. This guidance finalizes the draft guidance with the same name issued in May 2014. This guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI 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/2016/12/29/2016-31511.html","cfr_references":[],"citation":"81 FR 96010","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2014-D-0234"],"dockets":[],"document_number":"2016-31511","effective_on":null,"end_page":96011,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/12/29/2016-31511.xml","html_url":"https://www.federalregister.gov/documents/2016/12/29/2016-31511/clinical-pharmacology-data-to-support-a-demonstration-of-biosimilarity-to-a-reference-product","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-31511?publication_date=2016-12-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-12-29/2016-31511/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1022,"last_updated":"2026-08-25 14:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-12-29/pdf/2016-31511.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-31511.pdf?1482932784","publication_date":"2016-12-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/12/29/2016-31511.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2014-D-0234","supporting_documents_count":0,"docket_id":"FDA-2014-D-0234","regulation_id_number":null,"title":"Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product","checked_regulationsdotgov_at":"2017-01-18T06:00:25Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":96010,"subtype":null,"title":"Clinical Pharmacology Data To Support a Demonstration of Biosimilarity to a Reference Product; Guidance for Industry; Availability","toc_doc":"Clinical Pharmacology Data to Support Demonstration of Biosimilarity to Reference Product","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":81}