{"id":4875,"date":"2026-08-17T10:35:48","date_gmt":"2026-08-17T13:35:48","guid":{"rendered":"https:\/\/feadv.com.br\/?p=4875"},"modified":"2026-08-17T10:35:48","modified_gmt":"2026-08-17T13:35:48","slug":"anvisa-consolidates-understanding-on-interchangeability-between-biological-medicines-and-biosimilars","status":"publish","type":"post","link":"https:\/\/feadv.com.br\/en\/anvisa-consolida-o-entendimento-sobre-intercambialidade-entre-medicamentos-biologicos-e-biossimilares\/","title":{"rendered":"ANVISA consolidates understanding on interchangeability between biological and biosimilar medicines"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"4875\" class=\"elementor elementor-4875\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-18a470c4 e-flex e-con-boxed e-con e-parent\" data-id=\"18a470c4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4fb89604 elementor-widget elementor-widget-text-editor\" data-id=\"4fb89604\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">In June 2026, the Brazilian Health Regulatory Agency published Technical Note No. 60\/2026, a document that updates the national regulatory stance on the substitution of biosimilars for their respective biological comparators.<\/span><\/p><p><span style=\"font-weight: 400;\">The publication represents a milestone for the biotechnology market, with practical implications for the production chain, healthcare service providers, and patients undergoing high-complexity therapy.<\/span><\/p><h3><b><br \/><\/b><strong>What ANVISA understands by interchangeability<\/strong><\/h3><p><span style=\"font-weight: 400;\">The Agency defines this condition as the scientific recognition that two drugs are completely interchangeable, maintaining the expectation of the same clinical and safety outcome.<\/span><\/p><p><span style=\"font-weight: 400;\">Technical Note No. 60\/2026 authorizes alternation both between the biological comparator and its respective biosimilar, and between biosimilars that share the same reference product, provided that the approved guidelines for use are observed.<\/span><\/p><h3><b><br \/>The scientific and regulatory foundations of positioning<\/b><\/h3><p><span style=\"font-weight: 400;\">To establish this guideline, ANVISA analyzed data accumulated by partner international agencies and formal recommendations from the World Health Organization (WHO).<\/span><\/p><p><span style=\"font-weight: 400;\">The Agency's technical staff concluded that biosimilar options deliver identical efficacy and that the treatment transition entails no additional risks of immunogenicity or loss of therapeutic response.<\/span><\/p><p><span style=\"font-weight: 400;\">This global alignment provides greater predictability for companies operating in the Brazilian market.<\/span><\/p><h3><b><br \/>The requirements for switching between medications<\/b><\/h3><p><span style=\"font-weight: 400;\">To make the replacement feasible safely on a daily basis, ANVISA requires compliance with three pillars:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Informational transparency: <\/b><span style=\"font-weight: 400;\">clear communication with the patient and the inclusion of detailed information in the package insert intended for prescribers;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Sector-specific training: <\/b><span style=\"font-weight: 400;\">training of medical teams, pharmaceutical teams, and hospital managers on transition protocols; and<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Traceability control: <\/b><span style=\"font-weight: 400;\">Accurate identification of the medication and the batch dispensed.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\"><br \/>Compliance with these rules is a prerequisite for the rotation to be considered in good standing by health inspection agencies.<\/span><\/p><h3>\u00a0<\/h3><h3><b>The Impact on the Pharmaceutical Market<\/b><\/h3><p><span style=\"font-weight: 400;\">The new understanding strengthens the competitiveness of biosimilars compared to reference therapies. The document is intended to guide the strategic and commercial planning of companies in the sector, impacting their participation in public tenders and negotiations for the adoption of new technologies within the SUS and the supplemental health care ecosystem.<\/span><\/p><p><span style=\"font-weight: 400;\">In addition, companies are required to take a proactive approach to pharmacovigilance and the reporting of adverse events, ensuring the post-marketing monitoring of their products.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3bbd9f0 e-flex e-con-boxed e-con e-parent\" data-id=\"3bbd9f0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f69a99c elementor-widget elementor-widget-n-accordion\" data-id=\"f69a99c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2580\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-2580\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Is the substitution of biologics for biosimilars authorized in the Brazilian market?  <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2580\" class=\"elementor-element elementor-element-388cadc e-con-full e-flex e-con e-child\" data-id=\"388cadc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2580\" class=\"elementor-element elementor-element-4b4e72c e-flex e-con-boxed e-con e-child\" data-id=\"4b4e72c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-aadc7fe elementor-widget elementor-widget-text-editor\" data-id=\"aadc7fe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Yes. With the publication of Technical Note No. 60\/2026, ANVISA formally authorizes interchangeability between reference biologics and biosimilars, as well as between different biosimilars of the same comparator, provided that the limits set forth in the package insert are observed.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2581\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2581\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What administrative and operational requirements must industry stakeholders meet? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2581\" class=\"elementor-element elementor-element-69e932f e-con-full e-flex e-con e-child\" data-id=\"69e932f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2581\" class=\"elementor-element elementor-element-995a225 e-flex e-con-boxed e-con e-child\" data-id=\"995a225\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-232635e elementor-widget elementor-widget-text-editor\" data-id=\"232635e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Regular substitution presupposes transparent communication with the end user, technical instruction of the healthcare professionals responsible for the prescription, and the guarantee of complete traceability of the medicine batch.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2582\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2582\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which pharmaceutical business areas need to comply with the new guideline?  <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewbox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2582\" class=\"elementor-element elementor-element-19f6aad e-con-full e-flex e-con e-child\" data-id=\"19f6aad\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2582\" class=\"elementor-element elementor-element-ed48083 e-flex e-con-boxed e-con e-child\" data-id=\"ed48083\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8cdcb52 elementor-widget elementor-widget-text-editor\" data-id=\"8cdcb52\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>The departments of government relations, market intelligence, and pharmacovigilance need to review their business strategies for participating in public tenders and monitoring post-market safety.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5b9b33f e-flex e-con-boxed e-con e-parent\" data-id=\"5b9b33f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ebb22a8 elementor-widget elementor-widget-text-editor\" data-id=\"ebb22a8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h3><strong>Life Sciences and Healthcare<\/strong><\/h3><p>Fialdini Einsfeld Advogados provides regulatory and legal advisory services to pharmaceutical companies, biosimilar manufacturers, clinical trial sponsors, and other stakeholders in the healthcare sector. Our team monitors regulatory updates from ANVISA and CMED to support clients in implementing regulatory strategies that are sound and in compliance with current laws and regulations.<\/p><h4><strong><br \/>References<\/strong><\/h4><p><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2026\/anvisa-atualiza-entendimento-sobre-intercambialidade-de-biossimilares\">ANVISA Technical Note No. 60\/2026<\/a><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Em junho de 2026, a Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria publicou a Nota T\u00e9cnica n.\u00ba 60\/2026, documento que atualiza o posicionamento regulat\u00f3rio nacional sobre a substitui\u00e7\u00e3o de biossimilares por seus respectivos comparadores biol\u00f3gicos. A publica\u00e7\u00e3o representa um marco para o mercado de biotecnologia, com implica\u00e7\u00f5es pr\u00e1ticas para a cadeia produtiva, prestadores de servi\u00e7os de sa\u00fade [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[32],"tags":[35,36],"ppma_author":[33,34],"class_list":["post-4875","post","type-post","status-publish","format-standard","hentry","category-life-sciences-e-healthcare","tag-direito-regulatorio","tag-direito-sanitario"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ANVISA consolida o entendimento sobre intercambialidade entre medicamentos biol\u00f3gicos e biossimilares - Fialdini Einsfeld Advogados<\/title>\n<meta name=\"description\" content=\"A ANVISA publicou a Nota T\u00e9cnica n.\u00ba 60\/2026, que consolida o entendimento regulat\u00f3rio sobre a intercambialidade entre medicamentos biol\u00f3gicos e biossimilares.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/feadv.com.br\/en\/anvisa-consolidates-understanding-on-interchangeability-between-biological-medicines-and-biosimilars\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANVISA consolida o entendimento sobre intercambialidade entre medicamentos biol\u00f3gicos e biossimilares - 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