{"id":1125,"date":"2026-07-06T07:59:09","date_gmt":"2026-07-06T10:59:09","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&#038;p=1125"},"modified":"2026-07-06T07:59:09","modified_gmt":"2026-07-06T10:59:09","slug":"anvisa-informative-note-no-1-2026-ggbio-dire2","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2026\/07\/06\/anvisa-informative-note-no-1-2026-ggbio-dire2\/","title":{"rendered":"ANVISA \u2013 Informative Note No. 1\/2026\/GGBIO\/DIRE2: updated guidance on the evaluation of comparative pharmacokinetic studies for biosimilars"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">ANVISA published, on June\u00a029, 2026, Informative Note No.\u00a01\/2026\/SEI\/GGBIO\/DIRE2, updating guidance on the evaluation of comparative pharmacokinetic (PK) studies for biosimilars submitted as supporting evidence for registration and for the approval of Clinical Drug Development Dossiers (DDCMs).<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><!--more--><\/p>\n<p><span style=\"font-weight: 400;\">The main operational change introduced by the Note is the centralization of the evaluation of these studies under the Biological Products Evaluation Office (GPBIO\/GGBIO\/DIRE2). The measure aims to streamline and integrate the technical analysis of dossier elements, and is aligned with Art.\u00a08 of RDC No.\u00a0875\/2024, which provides for the possibility of waiving clinical studies and\/or comparative clinical evaluation parameters upon compliance with certain conditions.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In this context, pharmacokinetic data assume an even more central role in demonstrating comparability between the biosimilar and its reference biological product.<\/span><\/p>\n<p><b>Submission codes: what changes and what remains<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The submission codes remain the same:\u00a0\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"><strong>10846 \u2013 Biological Product \u2013<\/strong> Pharmacokinetic study: used at the time of submission of a biosimilar\u2019s registration dossier, with the protocol to be linked to the main petition (registration process). All PK studies related to the main petition must be included in a single dossier linked to this code.\u00a0\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\"><strong>10900 \u2013 Clinical Trials \u2013<\/strong> Comparative pharmacokinetic studies for investigational medicines \u2013 Biosimilars \u2013 submitted as DDCM: used when the DDCM contains completed comparative PK studies used as supporting evidence for subsequent phases. Submission is made as a secondary petition linked to the DDCM petition. When clinical development is limited to comparative PK studies (relative bioavailability), DDCM submission is not required.\u00a0\u00a0<\/span><\/li>\n<\/ul>\n<p><b>Complementary evaluation: GPBIO and COPEC<\/b><\/p>\n<p><span style=\"font-weight: 400;\">For studies linked to DDCMs, evaluation will be carried out jointly by the GPBIO and the Coordination of Clinical Research in Medicines and Biological Products (COPEC), each acting within its specific competencies. The comparative PK study must be included in the Investigational Medicinal Product Development Plan and in the Investigator\u2019s Brochure for COPEC review. Requirements may be issued by both areas regarding relative bioavailability studies.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Conclusion of the DDCM analysis is contingent on the GPBIO\u2019s final opinion on the comparative PK study. In cases of prioritized review, under the terms of RDC No. 1001\/2025, linked to a subject code 10900 petition, COPEC and GPBIO must issue their positions within 45 days from the granting of prioritization. If the applicant has not filed under subject code 10900 by the time prioritization is granted, the deadline for GPBIO&#8217;s first response begins counting from the filing date of the subject code 10900 submission.\u00a0<\/span><\/p>\n<p><b>Reuse of previously evaluated studies\u00a0\u00a0<\/b><\/p>\n<p><span style=\"font-weight: 400;\">When PK studies have already been evaluated by the GPBIO during clinical development, resubmission of the same documentation at the time of registration is not required. It is sufficient to indicate, via the code\u00a010846 submission, the reference number of the previously approved code\u00a010900 dossier.\u00a0\u00a0<\/span><\/p>\n<p><b>Revoked documents\u00a0\u00a0<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The Informative Note revokes the following prior documents on the subject:\u00a0\u00a0<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">Clarification Note No. 002\/2015\/GPBIO\/GGPBS\/SUMED\/ANVISA;\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Technical Note No. 118\/2016\/GGMED\/ANVISA-MS;\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Q&amp;A document dated March 3, 2017 (validation of binding assays for bioequivalence and pharmacokinetic comparability studies); and\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Q&amp;A document dated March 14, 2019 (documents for the analysis of comparative pharmacokinetic studies of biological products).\u00a0\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Documentation for PK studies submitted under codes 10846 and 10900 must follow the respective checklists available at <a href=\"https:\/\/consultas.anvisa.gov.br\/#\/consultadeassuntos\/\">https:\/\/consultas.anvisa.gov.br\/#\/consultadeassuntos\/<\/a>.<\/span><\/p>\n","protected":false},"author":3,"featured_media":1126,"template":"","meta":{"inline_featured_image":false,"_links_to":"","_links_to_target":""},"categorias":[22],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ANVISA \u2013 Informative Note No. 1\/2026\/GGBIO\/DIRE2: updated guidance on the evaluation of comparative pharmacokinetic studies for biosimilars<\/title>\n<meta name=\"description\" content=\"ANVISA published, on June 29, 2026, Informative Note No. 1\/2026\/SEI\/GGBIO\/DIRE2, updating guidance on the evaluation of comparative pharmacokinetic (PK) studies for biosimilars submitted as supporting 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