{"id":12168,"date":"2026-05-31T04:36:09","date_gmt":"2026-05-31T07:36:09","guid":{"rendered":"https:\/\/oexpressobr.com.br\/?p=12168"},"modified":"2026-05-31T04:36:10","modified_gmt":"2026-05-31T07:36:10","slug":"anvisa-define-teto-de-preco-para-a-semaglutida-da-ems-igual-ao-do-ozempic-e-wegovy","status":"publish","type":"post","link":"https:\/\/oexpressobr.com.br\/?p=12168","title":{"rendered":"Anvisa define teto de pre\u00e7o para a semaglutida da EMS igual ao do Ozempic e Wegovy"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><br>A primeira caneta de semaglutida 100% brasileira deu o passo definitivo para estrear nas prateleiras das farm\u00e1cias. A C\u00e2mara de Regula\u00e7\u00e3o do Mercado de Medicamentos (CMED), \u00f3rg\u00e3o vinculado \u00e0 Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa), determinou o Pre\u00e7o M\u00e1ximo ao Consumidor (PMC) para o medicamento Ozivy, desenvolvido pelo laborat\u00f3rio farmac\u00eautico nacional EMS.<br>O teto de pre\u00e7o fixado pelo \u00f3rg\u00e3o regulador ficou em R$ 1.077,79 (valor base sem a incid\u00eancia de impostos regionais) para as canetas de 1,5 ml \u2014 exatamente o mesmo limite aplic\u00e1vel aos concorrentes estrangeiros de refer\u00eancia, o Ozempic e o Wegovy, ambos fabricados pela dinamarquesa Novo Nordisk.<br>A paridade regulat\u00f3ria ocorreu porque a CMED enquadrou o Ozivy na chamada \u201ccategoria 4\u201d, destinada a novas apresenta\u00e7\u00f5es de subst\u00e2ncias que j\u00e1 possuem similares consolidados no mercado nacional. No entanto, o pre\u00e7o m\u00e1ximo estipulado funciona apenas como um teto legal, o que abre espa\u00e7o para uma forte concorr\u00eancia comercial.<br><strong>Fabricante promete pre\u00e7o at\u00e9 30% menor<\/strong><br>Apesar da autoriza\u00e7\u00e3o para atuar no teto m\u00e1ximo das multinacionais, a EMS j\u00e1 anunciou publicamente que adotar\u00e1 uma estrat\u00e9gia agressiva para conquistar fatias de mercado. A farmac\u00eautica brasileira planeja comercializar o medicamento com valores cerca de 30% inferiores aos da concorr\u00eancia direta. Como as vers\u00f5es de menor dosagem do Ozempic flutuam atualmente na casa dos R$ 900, a proje\u00e7\u00e3o \u00e9 de que o produto nacional chegue ao consumidor final custando por volta de R$ 630.<br>O valor definitivo em cada regi\u00e3o, contudo, flutuar\u00e1 devido ao Imposto sobre Circula\u00e7\u00e3o de Mercadorias e Servi\u00e7os (ICMS). Em S\u00e3o Paulo, onde a al\u00edquota \u00e9 de 18%, o limite regulat\u00f3rio m\u00e1ximo pode alcan\u00e7ar at\u00e9 R$ 1.314,37. J\u00e1 no estado de Alagoas, cuja al\u00edquota \u00e9 de 19%, o teto regulat\u00f3rio bruto sobe para R$ 1.330,60. Para as embalagens contendo duas canetas aplicadoras de 1,5 ml, o pre\u00e7o de f\u00e1brica teto aprovado ficou estabelecido em R$ 1.606,88 (sem ICMS).<br><strong>Indica\u00e7\u00e3o formal e mercado de gen\u00e9ricos<\/strong><br>Embora o princ\u00edpio ativo da semaglutida seja globalmente conhecido e receitado de forma <em>off-label<\/em> (fora da bula) para a perda de peso cr\u00f4nica, o Ozivy obteve a sua aprova\u00e7\u00e3o inicial na Anvisa voltada exclusivamente ao tratamento de diabetes tipo 2. A EMS informou que j\u00e1 submeteu um pedido de amplia\u00e7\u00e3o de indica\u00e7\u00e3o terap\u00eautica junto \u00e0s autoridades regulat\u00f3rias para abranger tamb\u00e9m o tratamento da obesidade, mas, no momento do lan\u00e7amento, a divulga\u00e7\u00e3o oficial seguir\u00e1 estritamente as diretrizes atuais de bula para diabetes.<br>Ao todo, a empresa nacional foi autorizada a fabricar quatro apresenta\u00e7\u00f5es comerciais da solu\u00e7\u00e3o injet\u00e1vel (todas na concentra\u00e7\u00e3o de 1,34 mg\/ml), que variam entre cartuchos com uma ou duas canetas e volumes de 1,5 ml e 3 ml.<br>A aprova\u00e7\u00e3o do pre\u00e7o do Ozivy \u00e9 o \u00e1pice de uma corrida de patentes no Brasil. No in\u00edcio deste ano, a Anvisa contabilizava pelo menos 17 pedidos de registros de medicamentos gen\u00e9ricos ou biosimilares baseados em semaglutida. O avan\u00e7o da ind\u00fastria nacional promete reconfigurar os custos da terapia metab\u00f3lica no pa\u00eds, facilitando o acesso ao tratamento e for\u00e7ando uma readequa\u00e7\u00e3o de pre\u00e7os por parte dos laborat\u00f3rios estrangeiros.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A primeira caneta de semaglutida 100% brasileira deu o passo definitivo para estrear nas prateleiras das farm\u00e1cias. A C\u00e2mara de Regula\u00e7\u00e3o do Mercado de Medicamentos [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":12170,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAowsargCw:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[18],"tags":[],"class_list":["post-12168","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-saude"],"desktop_mode_lock":null,"desktop_mode_contributors":[],"desktop_mode_attached_media":[12170],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Anvisa define teto de pre\u00e7o para a semaglutida da EMS igual ao do Ozempic e Wegovy - O Expresso BR<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/oexpressobr.com.br\/?p=12168\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Anvisa define teto de pre\u00e7o para a semaglutida da EMS igual ao do Ozempic e Wegovy - O Expresso BR\" \/>\n<meta property=\"og:description\" content=\"A primeira caneta de semaglutida 100% brasileira deu o passo definitivo para estrear nas prateleiras das farm\u00e1cias. 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