{"id":36880,"date":"2025-08-25T12:27:19","date_gmt":"2025-08-25T15:27:19","guid":{"rendered":"https:\/\/staging.portaltela.com\/noticias\/2025\/08\/25\/anvisa-prioriza-registro-de-medicamento-generico-similar-ao-ozempic\/"},"modified":"2025-08-25T12:27:19","modified_gmt":"2025-08-25T15:27:19","slug":"anvisa-prioriza-registro-de-medicamento-generico-similar-ao-ozempic","status":"publish","type":"post","link":"http:\/\/18.210.195.80\/cotidiano\/saude-cotidiano\/2025\/08\/25\/anvisa-prioriza-registro-de-medicamento-generico-similar-ao-ozempic\/","title":{"rendered":"Anvisa prioriza registro de medicamento gen\u00e9rico similar ao Ozempic"},"content":{"rendered":"

A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa)<\/strong> anunciou que dar\u00e1 prioridade \u00e0 an\u00e1lise de medicamentos gen\u00e9ricos e similares da semaglutida<\/strong> e liraglutida<\/strong>, subst\u00e2ncias ativas do Ozempic<\/strong> e Saxenda<\/strong>, respectivamente. O edital publicado permite que empresas que protocolarem pedidos de registro at\u00e9 o dia 25 deste m\u00eas solicitem an\u00e1lise priorit\u00e1ria, com um prazo de 15 dias para essa solicita\u00e7\u00e3o.<\/p>\n

A decis\u00e3o da Anvisa visa garantir o abastecimento<\/strong> do mercado brasileiro, considerando a instabilidade na oferta desses medicamentos, conforme identificado pela fiscaliza\u00e7\u00e3o da ag\u00eancia. Al\u00e9m disso, a medida atende a um pedido do Minist\u00e9rio da Sa\u00fade<\/strong>, que ressaltou a import\u00e2ncia de atender \u00e0s necessidades do Sistema \u00danico de Sa\u00fade (SUS)<\/strong> e promover a produ\u00e7\u00e3o nacional de medicamentos.<\/p>\n

Contexto da Medida<\/h3>\n

Atualmente, a ind\u00fastria nacional de medicamentos atende a 42%<\/strong> das demandas do Brasil. O objetivo do Minist\u00e9rio da Sa\u00fade \u00e9 aumentar essa capacidade para 70%<\/strong>. A Anvisa destaca que a an\u00e1lise de medicamentos an\u00e1logos de GLP-1, como os mencionados, \u00e9 complexa e requer dados extensos de comparabilidade e, em alguns casos, ensaios de imunogenicidade.<\/p>\n

Os pedidos que receberem prioridade ser\u00e3o analisados em ordem cronol\u00f3gica, com prefer\u00eancia para aqueles que incluem etapas de fabrica\u00e7\u00e3o no Brasil. A Anvisa possui capacidade para avaliar at\u00e9 tr\u00eas pedidos de medicamentos sint\u00e9ticos e tr\u00eas de biol\u00f3gicos por semestre, devido a limita\u00e7\u00f5es operacionais.<\/p>\n

Situa\u00e7\u00e3o Atual dos Pedidos<\/h3>\n

At\u00e9 o dia 6 deste m\u00eas, havia nove pedidos<\/strong> de registro relacionados \u00e0 semaglutida e sete<\/strong> \u00e0 liraglutida, todos aguardando an\u00e1lise. Al\u00e9m disso, tr\u00eas processos relacionados a insumos biol\u00f3gicos estavam em fase inicial. A Anvisa informa que a an\u00e1lise desses medicamentos \u00e9 uma das mais desafiadoras, exigindo um conhecimento t\u00e9cnico espec\u00edfico dos profissionais envolvidos.<\/p>\n","protected":false},"excerpt":{"rendered":"

    \n
  • A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) priorizar\u00e1 a an\u00e1lise de medicamentos gen\u00e9ricos e similares da semaglutida e liraglutida.<\/li>\n
  • O edital permite que empresas solicitem an\u00e1lise priorit\u00e1ria at\u00e9 o dia 25 deste m\u00eas, com um prazo de 15 dias para a solicita\u00e7\u00e3o.<\/li>\n
  • A medida visa garantir o abastecimento no Brasil e atender \u00e0s necessidades do Sistema \u00danico de Sa\u00fade (SUS).<\/li>\n
  • A ind\u00fastria nacional de medicamentos atualmente atende 42% das demandas do pa\u00eds, com o objetivo do Minist\u00e9rio da Sa\u00fade de aumentar essa capacidade para 70%.<\/li>\n
  • At\u00e9 o dia 6 deste m\u00eas, havia nove pedidos de registro relacionados \u00e0 semaglutida e sete \u00e0 liraglutida aguardando an\u00e1lise.<\/li>\n<\/ul>\n","protected":false},"author":15,"featured_media":36915,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"summary":"Anvisa prioriza an\u00e1lise de gen\u00e9ricos de semaglutida e liraglutida para atender demanda do SUS e aumentar produ\u00e7\u00e3o nacional de medicamentos","footnotes":""},"categories":[15,28],"tags":[159,94,98,92,122,186],"class_list":["post-36880","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cotidiano","category-saude-cotidiano","tag-doencas","tag-economia","tag-pesquisa","tag-presidente","tag-saude-mental","tag-tratamentos"],"yoast_head":"\nAnvisa prioriza registro de medicamento gen\u00e9rico similar ao Ozempic - Portal Tela (STAGING)<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Anvisa prioriza registro de medicamento gen\u00e9rico similar ao Ozempic\" \/>\n<meta property=\"og:description\" content=\"A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) priorizar\u00e1 a an\u00e1lise de medicamentos gen\u00e9ricos e similares da semaglutida e liraglutida. 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