{"id":4681,"date":"2018-10-29T15:55:09","date_gmt":"2018-10-29T15:55:09","guid":{"rendered":"https:\/\/blog.kolabtree.com\/?p=4681"},"modified":"2020-11-08T16:48:44","modified_gmt":"2020-11-08T16:48:44","slug":"biosimilars-benefits-challenges-and-future","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/","title":{"rendered":"Biosimilares: Benef\u00edcios, Desafios e Futuro"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Tabela de Conte\u00fados<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f34fac16b90\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f34fac16b90\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#Biologics\" title=\"Biol\u00f3gicos\">Biol\u00f3gicos<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#The_Case_for_Biosimilars\" title=\"O caso do Biosimilars\">O caso do Biosimilars<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#Biosimilars_Landscape_in_EU_and_USA\" title=\"Biosimilares: Paisagem na UE e EUA\">Biosimilares: Paisagem na UE e EUA<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#Benefits_of_biosimilars\" title=\"Benef\u00edcios de biosimilares:\">Benef\u00edcios de biosimilares:<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#Cost_reduction_by_competition\" title=\"Redu\u00e7\u00e3o de custos pela concorr\u00eancia\">Redu\u00e7\u00e3o de custos pela concorr\u00eancia<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#Enhanced_patient_accessibility\" title=\"Maior acessibilidade aos pacientes\">Maior acessibilidade aos pacientes<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#Incentive_for_innovation\" title=\"Incentivo \u00e0 inova\u00e7\u00e3o\">Incentivo \u00e0 inova\u00e7\u00e3o<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#Biosimilars_Challenges\" title=\"Biosimilares: Desafios\">Biosimilares: Desafios<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#Patient_and_prescriber_education\" title=\"Educa\u00e7\u00e3o dos pacientes e dos prescritores\">Educa\u00e7\u00e3o dos pacientes e dos prescritores<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#Extrapolation_issue\" title=\"Quest\u00e3o de extrapola\u00e7\u00e3o\">Quest\u00e3o de extrapola\u00e7\u00e3o<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#The_interchangeability_question\" title=\"A quest\u00e3o da intercambialidade\">A quest\u00e3o da intercambialidade<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#Rare_diseases\" title=\"Doen\u00e7as raras\">Doen\u00e7as raras<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/#The_Future_of_Biologics_and_Biosimilars\" title=\"O Futuro da Biologia e do Biosimilar\">O Futuro da Biologia e do Biosimilar<\/a><\/li><\/ul><\/nav><\/div>\n<p>A biosimilar is a biological medicine that is highly similar to an already approved biological medicine. The biosimilars market is expected to triple in size to $15 billion by 2020, McKinsey\u00a0 predicts. By that alone, we see that these medicines can transform <a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">sa\u00fade<\/a>. A <a href=\"http:\/\/biosimilarscouncil.org\/wp-content\/uploads\/2017\/06\/Biosimilars-Myths-v-Facts-Infographic_FINAL-6-5-17-1.pdf\">relat\u00f3rio<\/a> pelo Conselho Biosimilars (2018) prev\u00ea que os biosimilares poder\u00e3o economizar at\u00e9 $250 bilh\u00f5es durante a pr\u00f3xima d\u00e9cada. Estes produtos podem melhorar o acesso dos pacientes \u00e0queles que dependem de tratamentos biol\u00f3gicos? Quais s\u00e3o os desafios e oportunidades? Isto inclui os benef\u00edcios do biosimilars:<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Biologics\"><\/span>Biol\u00f3gicos<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><a href=\"https:\/\/www.fda.gov\/aboutfda\/centersoffices\/officeofmedicalproductsandtobacco\/cber\/ucm133077.htm\">Biol\u00f3gicos<\/a> s\u00e3o mol\u00e9culas biol\u00f3gicas, provenientes de organismos vivos, utilizadas para diagnosticar, tratar e curar muitas doen\u00e7as cr\u00f4nicas e incapacitantes. As mol\u00e9culas biol\u00f3gicas tipicamente grandes e complexas - incluindo horm\u00f4nios e anticorpos monoclonais - s\u00e3o fabricadas a partir de microorganismos, c\u00e9lulas vegetais ou animais usando biotecnologia. A variabilidade natural dentro do organismo hospedeiro, resulta na variabilidade entre os v\u00e1rios lotes da mol\u00e9cula biol\u00f3gica ativa que est\u00e1 sendo produzida. Normalmente, estas variabilidades s\u00e3o m\u00ednimas e n\u00e3o alteram a fun\u00e7\u00e3o biol\u00f3gica. Atualmente, a biologia oferece uma das tecnologias mais avan\u00e7adas para progn\u00f3sticos cl\u00ednicos de muitas doen\u00e7as. O potencial terap\u00eautico dessas mol\u00e9culas varia de diabetes a doen\u00e7as auto-imunes a cancros. Uma grande desvantagem da biologia, apesar de sua alta demanda, \u00e9 o custo excessivo que a acompanha - uma grande barreira para os pacientes. Conhecer os benef\u00edcios dos biosimilares \u00e9 altamente necess\u00e1rio.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"The_Case_for_Biosimilars\"><\/span>O caso do Biosimilars<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>A carga de custos para o consumidor poderia aparentemente ser reduzida por uma segunda categoria de produtos biol\u00f3gicos, chamada <a href=\"https:\/\/en.wikipedia.org\/wiki\/Biosimilar\"><strong>Biosimilares<\/strong><\/a>. Os biossimilares s\u00e3o <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/Molecular-Biology?utm_source=Blog&amp;utm_medium=pPost&amp;utm_campaign=Biosimilars\">mol\u00e9culas biol\u00f3gicas<\/a> que s\u00e3o <em>\"altamente semelhante a uma medicina biol\u00f3gica de refer\u00eancia j\u00e1 aprovada\".<\/em>. Para ser qualificada como biosimilar, uma mol\u00e9cula deve demonstrar propriedades equivalentes em termos de <em>\"estrutura, atividade biol\u00f3gica e perfil de efic\u00e1cia, seguran\u00e7a e imunogenicidade\"<\/em>, para a mol\u00e9cula de refer\u00eancia original. Como os bi\u00f3logos, os biosimilares tamb\u00e9m s\u00e3o fabricados biologicamente. Assim, o processo \u00e9 naturalmente vari\u00e1vel, resultando em uma variabilidade inerente do medicamento de refer\u00eancia. Estas varia\u00e7\u00f5es tornam a caracteriza\u00e7\u00e3o e a aprova\u00e7\u00e3o regulamentar, uma tarefa desafiadora. Entretanto, se for poss\u00edvel provar que estas varia\u00e7\u00f5es n\u00e3o afetam a seguran\u00e7a cl\u00ednica e a efic\u00e1cia, o biosimilar seria considerado para aprova\u00e7\u00e3o pelos \u00f3rg\u00e3os reguladores.<\/p>\n<p>Uma mol\u00e9cula biol\u00f3gica de refer\u00eancia deve passar por uma aplica\u00e7\u00e3o \"aut\u00f4noma\" contendo todos os dados, incluindo <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/Clinical-Trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">ensaios cl\u00ednicos<\/a> demonstrando sua seguran\u00e7a e efic\u00e1cia. Quando a patente de um medicamento biol\u00f3gico original expira, outras empresas concorrentes podem solicitar aprova\u00e7\u00f5es de comercializa\u00e7\u00e3o para um produto biosimilar correspondente. O objetivo final de um programa de desenvolvimento biosimilar \u00e9 provar \"bio-similaridade\" com o medicamento de refer\u00eancia, em vez de estabelecer um perfil aut\u00f4nomo de seguran\u00e7a ou efic\u00e1cia. Assim, em vez de passar por um ensaio cl\u00ednico convencional, o biosimilar \u00e9 submetido a um ensaio cl\u00ednico comparativo para provar a falta de diferen\u00e7a cl\u00ednica em rela\u00e7\u00e3o \u00e0 mol\u00e9cula de refer\u00eancia. A mol\u00e9cula biosimilar pode ser usada para avaliar os conhecimentos sobre seguran\u00e7a e efic\u00e1cia obtidos nos anos de uso da mol\u00e9cula de refer\u00eancia.<\/p>\n<p>Do ponto de vista regulat\u00f3rio, o programa de desenvolvimento biosimilar n\u00e3o precisa repetir todo o programa de desenvolvimento cl\u00ednico como a mol\u00e9cula biol\u00f3gica de refer\u00eancia original. Esta vantagem reduz os custos incorridos por ambos: tanto pelos fabricantes quanto pelos consumidores. Al\u00e9m disso, poupa muitos volunt\u00e1rios e pacientes de se envolverem em ensaios desnecess\u00e1rios. Em geral, o caminho de aprova\u00e7\u00e3o para biosimilares \u00e9 muito mais \u00e1gil, mais simples e mais barato do que os bi\u00f3logos originais da marca. Consequentemente, os biosimilares permitem que os pacientes tenham acesso \u00e0s inova\u00e7\u00f5es m\u00e9dicas mais cedo e mais barato, sem comprometer a efic\u00e1cia ou seguran\u00e7a. Um abrangente <a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0305737216300172\">lista<\/a> de biosimilares que s\u00e3o aprovados pelo FDA e ou EMA podem ser encontrados <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6172013\/table\/t1-dic-7-212543\/?report=objectonly\">aqui<\/a>.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Biosimilars_Landscape_in_EU_and_USA\"><\/span>Biosimilares: Paisagem na UE e EUA<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>A Ag\u00eancia Europ\u00e9ia de Medicamentos (EMA) foi pioneira em uma rota dedicada \u00e0 aprova\u00e7\u00e3o de biosimilares na Uni\u00e3o Europ\u00e9ia (UE) e aprovou o primeiro biosimilar (<a href=\"https:\/\/www.omnitrope.com\/about\/about-omnitrope\/\">Omnitrope<\/a>) em 2006. Atualmente, a UE \u00e9 o mercado mais maduro para biosimilares, em todo o mundo. De fato, as regulamenta\u00e7\u00f5es estabelecidas pela UE deram o tom para o desenvolvimento de biosimilares no resto do mundo. <strong>Em mar\u00e7o de 2018, havia mais de 40 comiss\u00f5es da UE aprovadas biosimilares.<\/strong> Espera-se que este n\u00famero s\u00f3 aumente ainda mais com a cont\u00ednua expans\u00e3o do gasoduto de biosimilares para revis\u00e3o pela EMA. Na \u00faltima d\u00e9cada, os sistemas de sa\u00fade da UE observaram uma vantagem vis\u00edvel com a concorr\u00eancia no mercado de biosimilares. O mercado de biosimilares da UE foi projetado para crescer perto de $4 bilh\u00f5es at\u00e9 o final de 2018.<\/p>\n<p>Em contraste, o mercado biosimilar nos EUA ainda \u00e9 bastante plano e est\u00e1 emergindo lentamente \u00e0 medida que as diretrizes regulat\u00f3rias est\u00e3o sendo estabelecidas. A Food and Drug Agency (FDA) aprovou o primeiro biosimilar somente em 2015 (<a href=\"http:\/\/chemocare.com\/chemotherapy\/drug-info\/filgrastim.aspx\">Filgrastim<\/a>). <strong>A partir de julho de 2018, existiam apenas <a href=\"https:\/\/www.fda.gov\/drugs\/developmentapprovalprocess\/howdrugsaredevelopedandapproved\/approvalapplications\/therapeuticbiologicapplications\/biosimilars\/ucm580432.htm\">12 Biosimilares aprovados pela FDA<\/a> no mercado.<\/strong> Sem d\u00favida, os EUA s\u00e3o um pa\u00eds cr\u00edtico <a href=\"https:\/\/www.rdmag.com\/article\/2016\/04\/us-biosimilar-market-2016\">mercado para biosimilares<\/a>. No entanto, muitos fatores imprevis\u00edveis, incluindo os lit\u00edgios em andamento em torno de disputas de patentes entre os inovadores, podem estender o tempo at\u00e9 o mercado. De acordo com a RAND Corporation, os biosimilares poderiam reduzir os custos do sistema de sa\u00fade dos EUA em biologia por cerca de <a href=\"https:\/\/www.rand.org\/content\/dam\/rand\/pubs\/perspectives\/PE200\/PE264\/RAND_PE264.pdf\">$54 bilh\u00f5es<\/a> na pr\u00f3xima d\u00e9cada. Vejamos agora os benef\u00edcios do biosimilars.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Benefits_of_biosimilars\"><\/span>Benef\u00edcios de biosimilares:<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"Cost_reduction_by_competition\"><\/span>Redu\u00e7\u00e3o de custos pela concorr\u00eancia<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p>Os rem\u00e9dios biol\u00f3gicos podem ser realmente caros. Por exemplo, um medicamento biol\u00f3gico para o c\u00e2ncer pode custar centenas e milhares de d\u00f3lares por paciente anualmente. Ter m\u00faltiplos biosimilares no mercado ir\u00e1 quebrar o monop\u00f3lio do medicamento de refer\u00eancia e ajudar a reduzir os custos.<\/p>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"Enhanced_patient_accessibility\"><\/span>Maior acessibilidade aos pacientes<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p>Com mais biosimilares em circula\u00e7\u00e3o, mais pacientes em todo o mundo podem ter acesso a estas op\u00e7\u00f5es de tratamento.<\/p>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"Incentive_for_innovation\"><\/span>Incentivo \u00e0 inova\u00e7\u00e3o<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p>Biosimilares n\u00e3o podem ser comercializados at\u00e9 a expira\u00e7\u00e3o da patente do medicamento de refer\u00eancia. Ter novos produtos biol\u00f3gicos inovadores e patente\u00e1veis talvez seja necess\u00e1rio para manter uma grande fatia do mercado, ap\u00f3s a expira\u00e7\u00e3o das patentes. Assim, as empresas farmac\u00eauticas seriam encorajadas a investir mais em setores de P&amp;D de ponta para fomentar a inova\u00e7\u00e3o.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Biosimilars_Challenges\"><\/span>Biosimilares: Desafios<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Apesar de sua acessibilidade, os biosimilares enfrentam in\u00fameros desafios para encontrar aceita\u00e7\u00e3o. Alguns dos desafios cont\u00ednuos incluem:<\/p>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"Patient_and_prescriber_education\"><\/span>Educa\u00e7\u00e3o dos pacientes e dos prescritores<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p>Embora os biosimilares existam h\u00e1 mais de uma d\u00e9cada na UE, eles ainda s\u00e3o uma novidade para aqueles fora deste setor. De acordo com um <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4889091\/\">pesquisa em 2014<\/a>Quase 30% de pessoas que vivem com um diagn\u00f3stico disseram que sua escolha medicinal foi altamente influenciada pela identidade do fabricante do medicamento. A educa\u00e7\u00e3o em massa \u00e9 necess\u00e1ria tanto no setor de sa\u00fade quanto na ind\u00fastria farmac\u00eautica. Os prescritores podem ver os biosimilares como trabalho extra: rever dados cl\u00ednicos, discutir a substitui\u00e7\u00e3o com os farmac\u00eauticos, e assim por diante. A situa\u00e7\u00e3o \u00e9 ainda mais complicada pela concord\u00e2ncia das seguradoras em impor a mudan\u00e7a para biosimilares. O <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/Physics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">m\u00e9dicos<\/a>,<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/pharmacology?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\"> farmac\u00eautico<\/a> e pacientes, todos precisam ser esclarecidos e, posteriormente, convencidos dos benef\u00edcios de mudar para biosimilares.<\/p>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"Extrapolation_issue\"><\/span>Quest\u00e3o de extrapola\u00e7\u00e3o<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4894513\/\">Extrapola\u00e7\u00e3o<\/a> \u00e9 \"O processo de concess\u00e3o de uma indica\u00e7\u00e3o cl\u00ednica a um medicamento sem estudos pr\u00f3prios ou novos de seguran\u00e7a e efic\u00e1cia cl\u00ednica para apoiar essa indica\u00e7\u00e3o\". Se os biosimilares podem ser prescritos para indica\u00e7\u00f5es n\u00e3o rotuladas, que s\u00e3o aceit\u00e1veis para o medicamento de refer\u00eancia, \u00e9 uma \u00e1rea cinza. Devem ser estabelecidas diretrizes apropriadas para estas indica\u00e7\u00f5es. Caso contr\u00e1rio, hospitais e farm\u00e1cias ser\u00e3o for\u00e7ados a portar tanto a mol\u00e9cula de refer\u00eancia quanto a contraparte biosimilar; anulando os benef\u00edcios de custo de prescrever o biosimilar.<\/p>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"The_interchangeability_question\"><\/span>A quest\u00e3o da intercambialidade<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p>A intercambialidade indica se a altern\u00e2ncia entre dois produtos n\u00e3o influencia a efic\u00e1cia ou a seguran\u00e7a quando comparada a cada produto isoladamente. Embora existam algumas diretrizes para determinar isto, h\u00e1 incerteza, prevalecente nos n\u00edveis locais de prescritores e farm\u00e1cias. Se um farmac\u00eautico pode \"substituir\" uma mol\u00e9cula de refer\u00eancia por uma biosimilar intercambi\u00e1vel ou vice-versa, sem uma prescri\u00e7\u00e3o expl\u00edcita, \u00e9 outra via que busca a concilia\u00e7\u00e3o.<\/p>\n<ul>\n<li>\n<h3><span class=\"ez-toc-section\" id=\"Rare_diseases\"><\/span>Doen\u00e7as raras<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<\/li>\n<\/ul>\n<p>Os tratamentos de doen\u00e7as raras freq\u00fcentemente utilizam \"medicamentos \u00f3rf\u00e3os\" que est\u00e3o associados a altos custos. Embora existam biosimilares sendo desenvolvidos para estes medicamentos \u00f3rf\u00e3os, eles enfrentam muitos obst\u00e1culos pr\u00e1ticos. Primeiro, \u00e9 dif\u00edcil obter uma popula\u00e7\u00e3o suficientemente grande e n\u00e3o homog\u00eanea para os ensaios das fases I e III. Al\u00e9m disso, o custo de fabrica\u00e7\u00e3o de lotes suficientes do biosimilar para realizar estudos de variabilidade de lote para construir dados extensivos de comparabilidade, pode ser desproporcionalmente alto.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"The_Future_of_Biologics_and_Biosimilars\"><\/span>O Futuro da Biologia e do Biosimilar<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>A ind\u00fastria biosimilar e sua regulamenta\u00e7\u00e3o tem crescido a passos largos na \u00faltima d\u00e9cada. Com alguns dos bi\u00f3logos mais prescritos enfrentando a expira\u00e7\u00e3o da patente num futuro pr\u00f3ximo, o mercado de biosimilares est\u00e1 pronto para um crescimento adicional. A concorr\u00eancia do mercado impulsionada pelos biosimilares pode representar uma amea\u00e7a ao monop\u00f3lio da ind\u00fastria farmac\u00eautica de marca. Freq\u00fcentemente, os gigantes da ind\u00fastria farmac\u00eautica s\u00e3o vistos como impedindo as empresas biosimilares na rede de direitos de propriedade intelectual. Nos pr\u00f3ximos anos, as autoridades reguladoras precisam fornecer uma estrutura mais tang\u00edvel para abordar algumas \u00e1reas cinzentas na comercializa\u00e7\u00e3o e prescri\u00e7\u00e3o de biosimilares. Isto, acompanhado de educa\u00e7\u00e3o pr\u00e1tica\/consumidor, novos desenvolvimentos e modelos comerciais podem preparar o terreno para a cria\u00e7\u00e3o de novos biosimilares blockbuster. Aqui est\u00e3o os benef\u00edcios do biosimilars.<\/p>\n<p>&#8212;-<br \/>\n<b>Precisa de ajuda com a consultoria de <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/bioinformatics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">Bioinform\u00e1tico<\/a>? Alugue um\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/bioinformatics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">Bioinform\u00e1tica freelancer<\/a>\u00a0especialista<\/b><b>\u00a0em Kolabtree. \u00c9 gr\u00e1tis para postar seu projeto e receber or\u00e7amentos.<\/b><\/p>\n<p>Peritos relacionados:<br \/>\n<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/bioinformatics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">Contratar um bioinform\u00e1tico<\/a>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/Molecular-Biology?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">Contratar um Bi\u00f3logo Molecular\u00a0<\/a>\u00a0\u00a0 \u00a0\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">Contratar um bioestat\u00edstico<\/a><\/p>\n<p>Necessidade de consultar um cientista freelance? Escolha entre mais de 10.000 especialistas em <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Biosimilars\">Kolabtree<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>A biosimilar is a biological medicine that is highly similar to an already approved biological medicine. The biosimilars market is expected to triple in size to $15 billion by 2020, McKinsey\u00a0 predicts. By that alone, we see that these medicines can transform healthcare. A report by the Biosimilars Council (2018) predicts that biosimilars could save<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/\" title=\"Leia mais\">Leia mais<\/a><\/div>","protected":false},"author":43,"featured_media":4695,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,443,435],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Biosimilars: Benefits, Challenges and Future - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"The biosimilars market is expected to triple in size to $15 billion by 2020. Let&#039;s look at benefits of biosimilars.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/biosimilars-benefits-challenges-and-future\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Biosimilars: Benefits, Challenges and Future\" \/>\n<meta property=\"og:description\" content=\"The biosimilars market is expected to triple in size to $15 billion by 2020. 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