{"id":6126,"date":"2017-07-24T15:30:47","date_gmt":"2017-07-24T18:30:47","guid":{"rendered":"https:\/\/prodoctor.net\/blog\/?p=6126"},"modified":"2021-08-23T12:14:31","modified_gmt":"2021-08-23T15:14:31","slug":"anvisa-troca-produtos-biologicos-biossimilares","status":"publish","type":"post","link":"https:\/\/prodoctor.net\/blog\/anvisa-troca-produtos-biologicos-biossimilares\/","title":{"rendered":"Anvisa se posiciona quanto \u00e0 troca de produtos biol\u00f3gicos \u201cbiossimilares\u201d"},"content":{"rendered":"\n<p>Ultimamente a <strong>Anvisa<\/strong> tem recebido uma s\u00e9rie de <strong>questionamentos<\/strong> sobre a pr\u00e1tica m\u00e9dica da <strong>troca de um medicamento biol\u00f3gico por outro equivalente<\/strong>, a intercambialidade de produtos \u201cbiossimilares\u201d. A nota de esclarecimento n\u00ba 003\/2017, publicada pela Ag\u00eancia, al\u00e9m de expressar o entendimento do \u00f3rg\u00e3o sobre o tema, traz conceitos, posicionamentos internacionais e demais orienta\u00e7\u00f5es gerais ao p\u00fablico.<\/p>\n\n\n\n<p>De acordo com a nota, a troca de um produto biol\u00f3gico por outro <strong>\u00e9 de responsabilidade do profissional da sa\u00fade prescritor<\/strong>. O papel da Anvisa, como \u00f3rg\u00e3o regulat\u00f3rio, \u00e9 <strong>assegurar a qualidade, efic\u00e1cia e seguran\u00e7a do produto registrado<\/strong>, seja ele o produto \u201cbiossimilar\u201d ou o comparador.<\/p>\n\n\n\n<p>A Ag\u00eancia entende ser <strong>importante a avalia\u00e7\u00e3o m\u00e9dica<\/strong> no caso de intercambialidade de produtos \u201cbiossimilares\u201d e seus comparadores, tanto para fins de prescri\u00e7\u00e3o do produto <strong>adequado ao paciente<\/strong> quanto para fins de farmacovigil\u00e2ncia e acompanhamento p\u00f3s-mercado desses produtos.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Entenda a diferen\u00e7a<\/h3>\n\n\n\n<p><strong>Produto biol\u00f3gico comparador<\/strong> \u2013 Primeiro produto a ser registrado. Estudos estabelecidos comprovam efic\u00e1cia e seguran\u00e7a da mol\u00e9cula antes da efetiva\u00e7\u00e3o do registro sanit\u00e1rio no pa\u00eds.<\/p>\n\n\n\n<p><strong>Produto \u201cbiossimilar\u201d<\/strong> \u2013 Produtos biol\u00f3gicos registrados pela via de desenvolvimento por comparabilidade. Estudos s\u00e3o feitos para demonstrar que n\u00e3o existem diferen\u00e7as clinicamente significativas entre ambos os produtos.<\/p>\n\n\n\n<p>Saiba mais sobre <a href=\"https:\/\/prodoctor.net\/blog\/intercambialidade-de-medicamentos\/\" target=\"_blank\" rel=\"noopener noreferrer\">intercambialidade de medicamentos<\/a>.<\/p>\n\n\n\n<p>Fonte: <a href=\"http:\/\/portal.anvisa.gov.br\/resultado-de-busca?p_p_id=101&amp;p_p_lifecycle=0&amp;p_p_state=maximized&amp;p_p_mode=view&amp;p_p_col_id=column-1&amp;p_p_col_count=1&amp;_101_struts_action=%2Fasset_publisher%2Fview_content&amp;_101_assetEntryId=3437384&amp;_101_type=content&amp;_101_groupId=219201&amp;_101_urlTitle=e-a-troca-entre-medicamentos-biologicos-&amp;redirect=http%3A%2F%2Fportal.anvisa.gov.br%2Fresultado-de-busca%3Fp_p_id%3D3%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_mode%3Dview%26p_p_col_id%3Dcolumn-1%26p_p_col_count%3D1%26_3_groupId%3D0%26_3_keywords%3DNota%2Besclarece%2Bposicionamento%2Bda%2BAnvisa%2Bquanto%2B%25C3%25A0%2Btroca%2Bde%2Bprodutos%2Bbiol%25C3%25B3gicos%2B%25E2%2580%259Cbiossimilares%25E2%2580%259D%26_3_cur%3D1%26_3_struts_action%3D%252Fsearch%252Fsearch%26_3_format%3D%26_3_formDate%3D1441824476958&amp;inheritRedirect=true\" target=\"_blank\" rel=\"noopener noreferrer\">Anvisa<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ultimamente a Anvisa tem recebido uma s\u00e9rie de questionamentos sobre a pr\u00e1tica m\u00e9dica da troca de um medicamento biol\u00f3gico&#8230;<\/p>\n","protected":false},"author":2,"featured_media":19638,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kadence_starter_templates_imported_post":false,"_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"footnotes":""},"categories":[415],"tags":[],"class_list":["post-6126","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicamentos-e-farmacia"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Anvisa se posiciona sobre troca de produtos biol\u00f3gicos \u201cbiossimilares\u201d<\/title>\n<meta name=\"description\" content=\"Nota esclarece posicionamento da Anvisa quanto \u00e0 troca de produtos biol\u00f3gicos \u201cbiossimilares\u201d. 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Confira o post e fique por dentro dessa mudan\u00e7a.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/prodoctor.net\/blog\/anvisa-troca-produtos-biologicos-biossimilares\/\" \/>\n<meta property=\"og:site_name\" content=\"Blog ProDoctor\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/prodoctorsoftware\" \/>\n<meta property=\"article:published_time\" content=\"2017-07-24T18:30:47+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-08-23T15:14:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/prodoctor.net\/blog\/wp-content\/uploads\/2016\/11\/efeitos-medicamentos.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"770\" \/>\n\t<meta property=\"og:image:height\" content=\"400\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fernanda Oliveira\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@prodoctorsoft\" \/>\n<meta name=\"twitter:site\" content=\"@prodoctorsoft\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fernanda Oliveira\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/prodoctor.net\/blog\/anvisa-troca-produtos-biologicos-biossimilares\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/prodoctor.net\/blog\/anvisa-troca-produtos-biologicos-biossimilares\/\"},\"author\":{\"name\":\"Fernanda Oliveira\",\"@id\":\"https:\/\/prodoctor.net\/blog\/#\/schema\/person\/9d2c92975a3fd1e3b2950efdbebab143\"},\"headline\":\"Anvisa se posiciona quanto \u00e0 troca de produtos biol\u00f3gicos \u201cbiossimilares\u201d\",\"datePublished\":\"2017-07-24T18:30:47+00:00\",\"dateModified\":\"2021-08-23T15:14:31+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/prodoctor.net\/blog\/anvisa-troca-produtos-biologicos-biossimilares\/\"},\"wordCount\":241,\"publisher\":{\"@id\":\"https:\/\/prodoctor.net\/blog\/#organization\"},\"image\":{\"@id\":\"https:\/\/prodoctor.net\/blog\/anvisa-troca-produtos-biologicos-biossimilares\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/prodoctor.net\/blog\/wp-content\/uploads\/2016\/11\/efeitos-medicamentos.jpg\",\"articleSection\":[\"Medicamentos e Farm\u00e1cia\"],\"inLanguage\":\"pt-BR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/prodoctor.net\/blog\/anvisa-troca-produtos-biologicos-biossimilares\/\",\"url\":\"https:\/\/prodoctor.net\/blog\/anvisa-troca-produtos-biologicos-biossimilares\/\",\"name\":\"Anvisa se posiciona sobre troca de produtos biol\u00f3gicos \u201cbiossimilares\u201d\",\"isPartOf\":{\"@id\":\"https:\/\/prodoctor.net\/blog\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/prodoctor.net\/blog\/anvisa-troca-produtos-biologicos-biossimilares\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/prodoctor.net\/blog\/anvisa-troca-produtos-biologicos-biossimilares\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/prodoctor.net\/blog\/wp-content\/uploads\/2016\/11\/efeitos-medicamentos.jpg\",\"datePublished\":\"2017-07-24T18:30:47+00:00\",\"dateModified\":\"2021-08-23T15:14:31+00:00\",\"description\":\"Nota esclarece posicionamento da Anvisa quanto \u00e0 troca de produtos biol\u00f3gicos \u201cbiossimilares\u201d. 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