{"id":60678,"date":"2021-08-04T00:00:00","date_gmt":"2021-08-03T22:00:00","guid":{"rendered":"https:\/\/llyc.global\/2021\/08\/04\/biologicos-e-biossimilares-um-casamento-de-conveniencia-que-beneficia-a-sociedade\/"},"modified":"2021-08-04T00:00:00","modified_gmt":"2021-08-03T22:00:00","slug":"biologicos-e-biossimilares-um-casamento-de-conveniencia-que-beneficia-a-sociedade","status":"publish","type":"post","link":"https:\/\/llyc.global\/pt-br\/ideas\/biologicos-e-biossimilares-um-casamento-de-conveniencia-que-beneficia-a-sociedade\/","title":{"rendered":"BIOL\u00d3GICOS E BIOSSIMILARES: Um Casamento de Conveni\u00eancia que Beneficia a Sociedade"},"content":{"rendered":"

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A ind\u00fastria biofarmac\u00eautica pode manter a posi\u00e7\u00e3o favor\u00e1vel alcan\u00e7ada em 2020 e impulsionar a ado\u00e7\u00e3o de produtos biol\u00f3gicos e biossimilares inovadores?<\/strong><\/p>\n

Se o lan\u00e7amento de medicamentos biol\u00f3gicos (biotecnol\u00f3gicos) gerou pol\u00eamica por conta da novidade, a pol\u00eamica sobre os biossimilares foi maior. Neste momento, e apesar da experi\u00eancia adquirida ao longo de mais de 15 anos com o primeiro biossimilar lan\u00e7ado no mercado – e da atual regulamenta\u00e7\u00e3o r\u00edgida – ainda se questiona se esses medicamentos representam oportunidades ou riscos para pacientes, m\u00e9dicos e sistemas de sa\u00fade em termos de seguran\u00e7a, efic\u00e1cia e custos; Isso provavelmente se deve \u00e0 falta de informa\u00e7\u00e3o, comunica\u00e7\u00e3o difusa e falta de divulga\u00e7\u00e3o e educa\u00e7\u00e3o sobre a inova\u00e7\u00e3o cient\u00edfica em farmacobiologia e o valor que os medicamentos biol\u00f3gicos inovadores proporcionam, al\u00e9m da falta de conhecimento sobre as evid\u00eancias de efic\u00e1cia e seguran\u00e7a dos biossimilares ou biocompar\u00e1veis.<\/p>\n

Medicamentos biossimilares ou biocompar\u00e1veis \u200b\u200bgeraram inicialmente grande oposi\u00e7\u00e3o, pois n\u00e3o havia um padr\u00e3o claro de como avali\u00e1-los e d\u00favidas sobre sua seguran\u00e7a. Em um rio turbulento, algumas organiza\u00e7\u00f5es e empresas discutiram sobre direitos de propriedade intelectual e acentuaram as diferen\u00e7as entre os produtos. A isso foi adicionado que o nome \u2018biossimilar\u2019 n\u00e3o ajudou muito, pois tamb\u00e9m enfatizou as diferen\u00e7as, mas agora se sabe que biol\u00f3gicos inovadores tamb\u00e9m podem ter pequenas varia\u00e7\u00f5es ao longo do tempo, devido \u00e0 sua origem e processo de desenvolvimento e elabora\u00e7\u00e3o. Al\u00e9m do exposto, a falta de regulamenta\u00e7\u00e3o adequada, naquele momento, gerava confus\u00e3o e medo, principalmente na comunidade m\u00e9dica.<\/p>\n

A ind\u00fastria biofarmac\u00eautica contribuiu significativamente na busca de medicamentos e vacinas para o enfrentamento da pandemia de Covid19. Foi um momento hist\u00f3rico onde, gra\u00e7as \u00e0 colabora\u00e7\u00e3o e ao empenho, as op\u00e7\u00f5es terap\u00eauticas foram desenvolvidas em tempo recorde. Agora as empresas devem enfrentar as mudan\u00e7as, aproveitar o ambiente positivo para a inova\u00e7\u00e3o e promover um novo modelo de comunica\u00e7\u00e3o que favore\u00e7a a mudan\u00e7a nas intera\u00e7\u00f5es humanas e nas rela\u00e7\u00f5es com governos e institui\u00e7\u00f5es para garantir que cada vez mais pacientes recebam as terapias de que precisam.<\/p>\n

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[\/et_pb_text][et_pb_text admin_label=”Un poco de historia” _builder_version=”4.4.8″ text_text_shadow_horizontal_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength=”text_text_shadow_style,%91object Object%93″ text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength=”link_text_shadow_style,%91object Object%93″ link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength=”header_text_shadow_style,%91object Object%93″ header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

Um pouco de hist\u00f3ria<\/strong><\/h3>\n

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Os medicamentos biol\u00f3gicos surgiram na d\u00e9cada de 1980 gra\u00e7as ao esfor\u00e7o de cientistas e ao grande investimento das empresas farmac\u00eauticas. Com a chegada dos medicamentos biol\u00f3gicos, foi poss\u00edvel controlar e at\u00e9 curar algumas doen\u00e7as, o exemplo mais recente s\u00e3o as vacinas contra a Covid19. Esses tipos de medicamentos s\u00e3o produzidos a partir de organismos vivos e, desde a sua introdu\u00e7\u00e3o, revolucionaram o tratamento de doen\u00e7as imunol\u00f3gicas, c\u00e2ncer, diabetes, esclerose m\u00faltipla e doen\u00e7as raras, entre outras, melhorando significativamente a vida dos pacientes por sua maior efic\u00e1cia, rapidez de a\u00e7\u00e3o e tolerabilidade.<\/p>\n

A comunidade m\u00e9dica comemorou o lan\u00e7amento desses novos medicamentos biol\u00f3gicos que contaram com respaldo cient\u00edfico e representaram um avan\u00e7o no tratamento de doen\u00e7as cr\u00f4nicas e degenerativas, condi\u00e7\u00f5es que antes eram tratadas com paliativos que amenizavam os sintomas, mas que estavam longe de melhorar a qualidade de vida dos pacientes. e ainda mais de uma cura potencial.<\/p>\n

O problema e grande desafio das novas alternativas era – e continua sendo – seu custo. Ser\u00e1 necess\u00e1rio considerar que para a cria\u00e7\u00e3o desses biol\u00f3gicos, as empresas farmac\u00eauticas investem muito tempo e grandes recursos financeiros na pesquisa e no desenvolvimento de cada mol\u00e9cula, e o processo de fabrica\u00e7\u00e3o requer sofistica\u00e7\u00e3o e tecnologia de ponta em instala\u00e7\u00f5es e processos.<\/p>\n

Como os medicamentos gen\u00e9ricos, surgiram os biossimilares. Quando algumas patentes de medicamentos biol\u00f3gicos expiraram, outras empresas produziram vers\u00f5es semelhantes que rapidamente demonstraram efic\u00e1cia e seguran\u00e7a, embora sua entrada no mercado n\u00e3o tenha sido nada f\u00e1cil e ap\u00f3s 15 anos do lan\u00e7amento do primeiro medicamento biossimilar no mercado, ainda h\u00e1 um grande falta de conhecimento sobre essas alternativas de tratamento.<\/p>\n

    \n
  • Os biossimilares s\u00e3o uma op\u00e7\u00e3o para os sistemas de sa\u00fade, ap\u00f3s o estouro da pandemia?<\/li>\n
  • O que \u00e9 necess\u00e1rio para promover uma melhor compreens\u00e3o do valor de um medicamento biol\u00f3gico e da contribui\u00e7\u00e3o de um biossimilar?<\/li>\n
  • Como a ind\u00fastria biofarmac\u00eautica pode tirar proveito do comprometimento do posicionamento da ind\u00fastria recentemente alcan\u00e7ado com o desenvolvimento de medicamentos e vacinas em tempo recorde?<\/li>\n<\/ul>\n

    Neste artigo, abordamos essas quest\u00f5es de diferentes perspectivas e propomos cinco maneiras de obter o reconhecimento da contribui\u00e7\u00e3o da ind\u00fastria de biotecnologia em um ambiente p\u00f3s-Covid19.<\/p>\n

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    O que \u00e9 um medicamento biol\u00f3gico?<\/strong><\/h2>\n

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    Medicamento biol\u00f3gico \u00e9 definido como aquele que cont\u00e9m um ou mais princ\u00edpios ativos sintetizados ou derivados de uma fonte biol\u00f3gica, alguns deles j\u00e1 presentes no corpo humano. Os medicamentos biol\u00f3gicos s\u00e3o divididos em tr\u00eas categorias: anticorpos monoclonais; moduladores ou substitui\u00e7\u00f5es de enzimas; e moduladores ou substitui\u00e7\u00f5es da fun\u00e7\u00e3o do receptor na superf\u00edcie celular. Eles s\u00e3o geralmente fabricados por fermenta\u00e7\u00e3o, usando DNA recombinante ou outros m\u00e9todos biossint\u00e9ticos nos quais o processo de fabrica\u00e7\u00e3o, as linhas celulares e o processo de purifica\u00e7\u00e3o podem ter um impacto na qualidade, seguran\u00e7a e efic\u00e1cia do medicamento.<\/p>\n

     <\/p>\n

    [\/et_pb_text][et_pb_text admin_label=”OMS” _builder_version=”4.4.8″ text_text_shadow_horizontal_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength=”text_text_shadow_style,%91object Object%93″ text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength=”link_text_shadow_style,%91object Object%93″ link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength=”header_text_shadow_style,%91object Object%93″ header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

    OMS: regula\u00e7\u00e3o para o acesso e a garantia de seguran\u00e7a e efic\u00e1cia<\/strong><\/h2>\n

     <\/p>\n

    Para a Organiza\u00e7\u00e3o Mundial da Sa\u00fade (OMS), a import\u00e2ncia de melhorar o acesso aos produtos bioterap\u00eauticos e garantir sua qualidade, seguran\u00e7a e efic\u00e1cia \u00e9 muito importante. Em 2014, adotou uma resolu\u00e7\u00e3o que reconheceu os medicamentos biossimilares como produtos bioterap\u00eauticos semelhantes aos produtos de refer\u00eancia licenciados. Normalmente, os biossimilares s\u00e3o desenvolvidos ap\u00f3s a expira\u00e7\u00e3o das patentes originais, reduzindo substancialmente os custos e melhorando a disponibilidade de tratamento para os pacientes. A OMS decretou que os reguladores devem estabelecer supervis\u00e3o regulat\u00f3ria de biossimilares ao longo de seu ciclo de vida, para garantir que apenas biossimilares de alta qualidade, seguros e eficazes estejam dispon\u00edveis no mercado, garantindo tamb\u00e9m a capacidade de avaliar a qualidade, seguran\u00e7a e efic\u00e1cia., E controlar o uso de biossimilares nos sistemas p\u00fablicos de sa\u00fade.<\/p>\n

     <\/p>\n

    [\/et_pb_text][et_pb_text admin_label=”Diferencias entre este tipo de medicamentos” _builder_version=”4.4.8″ text_text_shadow_horizontal_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength=”text_text_shadow_style,%91object Object%93″ text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength=”link_text_shadow_style,%91object Object%93″ link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength=”header_text_shadow_style,%91object Object%93″ header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

    Para entender: existem diferen\u00e7as entre os medicamentos?<\/strong><\/h2>\n

     <\/p>\n

    Conforme observado, os produtos biol\u00f3gicos geralmente v\u00eam de organismos vivos que podem ser animais ou microorganismos, como leveduras e algumas bact\u00e9rias. Os medicamentos convencionais s\u00e3o sintetizados quimicamente e f\u00e1ceis de produzir porque as mol\u00e9culas n\u00e3o s\u00e3o complexas ou grandes e s\u00e3o fabricadas de acordo com uma ”receita qu\u00edmica”. Os produtos biol\u00f3gicos requerem um processo de produ\u00e7\u00e3o mais complicado porque s\u00e3o organismos vivos.<\/p>\n

    Segundo o FDA, um biossimilar \u00e9 um produto biol\u00f3gico semelhante ao da patente e n\u00e3o apresenta diferen\u00e7as clinicamente significativas de outro produto biol\u00f3gico j\u00e1 aprovado pela ag\u00eancia reguladora, conhecido como produto biol\u00f3gico original ou de refer\u00eancia. Os biossimilares s\u00e3o feitos dos mesmos tipos de fontes naturais que o medicamento original com o qual foram comparados, s\u00e3o administrados da mesma forma, t\u00eam a mesma concentra\u00e7\u00e3o e a mesma dosagem e t\u00eam os mesmos efeitos colaterais potenciais. De acordo com o FDA, um biossimilar oferece os mesmos benef\u00edcios de tratamento que o biol\u00f3gico original e \u00e9 seguro e eficaz, pois ambos s\u00e3o rigorosa e exaustivamente avaliados antes de serem aprovados por ag\u00eancias reguladoras, como o pr\u00f3prio FDA.\u00a0<\/p>\n

    Para a EMA (Ag\u00eancia Europeia de Medicamentos), um biossimilar \u00e9 um medicamento biol\u00f3gico semelhante a outro medicamento j\u00e1 comercializado na UE, denominado \u201cmedicamento de refer\u00eancia\u201d. As empresas podem comercializar os biossimilares autorizados, uma vez encerrado o per\u00edodo de prote\u00e7\u00e3o ao mercado dos medicamentos de refer\u00eancia. Ou seja, depois de dez anos.<\/p>\n

    \u00a0<\/strong><\/p>\n

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    \u201cDe acordo com o FDA, um biossimilar oferece os mesmos benef\u00edcios de tratamento que o biol\u00f3gico original e \u00e9 seguro e eficaz\u201d<\/h2>\n

    [\/et_pb_text][et_pb_image _builder_version=”4.4.8″ src=”https:\/\/ideasbr.llorenteycuenca.com\/wp-content\/uploads\/sites\/8\/2021\/08\/web_biologicos_1.png” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″ align=”center” \/][et_pb_text admin_label=”Controversia vs Experiencia.” _builder_version=”4.4.8″ text_text_shadow_horizontal_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength=”text_text_shadow_style,%91object Object%93″ text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength=”link_text_shadow_style,%91object Object%93″ link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength=”header_text_shadow_style,%91object Object%93″ header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

    \u00a0<\/h2>\n

    Controv\u00e9rsia X Experi\u00eancia<\/strong><\/h2>\n

     <\/p>\n

    Como foi destacado no in\u00edcio, o lan\u00e7amento dos biossimilares foi mais pol\u00eamico do que o dos inovadores de refer\u00eancia, pois a falta de evid\u00eancias sobre sua seguran\u00e7a e efic\u00e1cia foi questionada. Felizmente, j\u00e1 existe uma experi\u00eancia regulat\u00f3ria de mais de 10 anos que permite considerar os biossimilares como uma op\u00e7\u00e3o terap\u00eautica que beneficia mais pacientes, pois gera acesso a mais terapias e favorece os sistemas de sa\u00fade ao reduzir os custos dos medicamentos bioterap\u00eauticos.<\/p>\n

    A Uni\u00e3o Europeia autorizou o maior n\u00famero de biossimilares do mundo, o que representa a mais vasta experi\u00eancia na sua utiliza\u00e7\u00e3o e seguran\u00e7a. Ao longo dos anos, a EMA publicou diretrizes cient\u00edficas para ajudar os desenvolvedores de medicamentos a cumprir requisitos regulamentares estritos para a autoriza\u00e7\u00e3o de medicamentos biossimilares. Os padr\u00f5es evolu\u00edram para acompanhar os r\u00e1pidos avan\u00e7os em biotecnologia e ci\u00eancias anal\u00edticas e incorporar a experi\u00eancia crescente que o uso cl\u00ednico traz.<\/p>\n

     <\/p>\n

    [\/et_pb_text][et_pb_text admin_label=”Estudios Cl\u00ednicos” _builder_version=”4.4.8″ text_text_shadow_horizontal_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength=”text_text_shadow_style,%91object Object%93″ text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength=”link_text_shadow_style,%91object Object%93″ link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength=”header_text_shadow_style,%91object Object%93″ header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

    Estudos cl\u00ednicos: chave para diferenciar um biol\u00f3gico de um biossimilar<\/strong><\/h2>\n

     <\/p>\n

    Segundo Eduardo Cioppi, diretor global de Rela\u00e7\u00f5es P\u00fablicas da mABxience, empresa global que produz biof\u00e1rmacos, uma das principais diferen\u00e7as entre os biossimilares e os biol\u00f3gicos de refer\u00eancia \u00e9 o objetivo do programa de ensaios cl\u00ednicos que \u00e9 realizado durante seu desenvolvimento. Enquanto os biol\u00f3gicos devem demonstrar a efic\u00e1cia cl\u00ednica do produto, os biossimilares devem determinar que a farmacocin\u00e9tica, a farmacodin\u00e2mica, a seguran\u00e7a e a imunogenicidade s\u00e3o compar\u00e1veis \u00e0s do biol\u00f3gico de refer\u00eancia. Ou seja, demonstrar o conceito cient\u00edfico de comparabilidade para verificar que as pequenas diferen\u00e7as que podem ser encontradas entre eles n\u00e3o t\u00eam impacto relevante no resultado terap\u00eautico final.<\/p>\n

    De acordo com Eduardo Cioppi, as patentes de muito mais medicamentos expirar\u00e3o nos pr\u00f3ximos cinco anos do que nos 10 anos anteriores, o que significa que no mercado haver\u00e1 oportunidades para muito mais biossimilares e, assim, muitos pacientes se beneficiar\u00e3o com o acesso ao seu tratamento e os sistemas de sa\u00fade ser\u00e3o capazes de fazer um uso mais racional e eficaz de seus recursos e or\u00e7amentos; e acrescenta, \u201cos medicamentos biol\u00f3gicos inovadores s\u00e3o necess\u00e1rios porque deixam uma marca no tratamento de doen\u00e7as e as grandes empresas que investem no desenvolvimento de um merecido medicamento biol\u00f3gico t\u00eam anos de exclusividade para recuperar o investimento. Terminada a patente, deve-se dar espa\u00e7o para a entrada de alternativas t\u00e3o eficazes e seguras quanto a biol\u00f3gica inovadora e, para isso, as autoridades sanit\u00e1rias devem ter regulamenta\u00e7\u00e3o adequada que permita a ado\u00e7\u00e3o de biossimilares porque, al\u00e9m de serem seguras e eficazes, s\u00e3o produtos mais acess\u00edveis.<\/p>\n

     <\/p>\n

    [\/et_pb_text][et_pb_image _builder_version=”4.4.8″ src=”https:\/\/ideasbr.llorenteycuenca.com\/wp-content\/uploads\/sites\/8\/2021\/08\/web_biologicos_3.png” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″ align=”center” \/][et_pb_text admin_label=”El beneficio para pacientes y sistemas de salud” _builder_version=”4.4.8″ text_text_shadow_horizontal_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength=”text_text_shadow_style,%91object Object%93″ text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength=”link_text_shadow_style,%91object Object%93″ link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength=”header_text_shadow_style,%91object Object%93″ header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

    Oportunidade que beneficia pacientes e sistemas de sa\u00fade<\/strong><\/h2>\n

     <\/p>\n

    Para Crist\u00f3bal Thompson, diretor executivo da Associa\u00e7\u00e3o Mexicana de Ind\u00fastrias de Inova\u00e7\u00e3o Farmac\u00eautica (AMIIF), l\u00edder com vasta experi\u00eancia na ind\u00fastria farmac\u00eautica e com medicamentos biotecnol\u00f3gicos, a penetra\u00e7\u00e3o de biocompar\u00e1veis ou biossimilares ainda \u00e9 baixa no M\u00e9xico e na Am\u00e9rica Latina em compara\u00e7\u00e3o com o EUA e Europa, \u201cclaramente h\u00e1 uma oportunidade para biocompar\u00e1veis quando os prazos de patente e propriedade intelectual dos inovadores s\u00e3o respeitados. Vimos como os medicamentos biotecnol\u00f3gicos mudam drasticamente o curso da doen\u00e7a, pacientes com doen\u00e7as como a artrite reumat\u00f3ide que n\u00e3o conseguiam mais se mover, recuperavam o movimento, melhoravam sua sa\u00fade e qualidade de vida e podem retornar \u00e0 vida normal em um tempo muito curto. Estou convicto de que os dois tipos de f\u00e1rmacos devem coexistir, desde que os biocompar\u00e1veis tenham sido aprovados com o mesmo rigor cient\u00edfico dos inovadores, j\u00e1 representam um maior acesso a f\u00e1rmacos de qualidade para os pacientes, s\u00e3o desenvolvidos por grandes empresas, t\u00eam demonstrado seguran\u00e7a ao longo do tempo e foram aprovados por autoridades regulat\u00f3rias mais r\u00edgidas, como o FDA e a Ag\u00eancia Europeia de Medicamentos.<\/p>\n

    Sobre a regula\u00e7\u00e3o, Crist\u00f3bal Thompson considera que existe uma boa regula\u00e7\u00e3o e que pode, sem d\u00favida, ser melhorada, e que neste sentido alguns aspectos est\u00e3o sendo revistos para obter a homologa\u00e7\u00e3o com as normas internacionais.<\/p>\n

    Em rela\u00e7\u00e3o \u00e0 confian\u00e7a dos m\u00e9dicos, que inicialmente relutaram em usar drogas biol\u00f3gicas porque precisavam de infus\u00e3o, \u00e9 importante que as empresas trabalhem duro para gerar essa confian\u00e7a e que tamb\u00e9m se envolvam na comunica\u00e7\u00e3o com todas as partes envolvidas na aprova\u00e7\u00e3o e uso desse tipo da medica\u00e7\u00e3o, inclusive dos pacientes, pois \u00e9 muito importante que eles, que v\u00e3o receber a medica\u00e7\u00e3o, estejam bem informados e tenham uma voz mais ativa durante todo o processo.<\/p>\n

     <\/p>\n

    [\/et_pb_text][et_pb_text admin_label=”El rol de los pacientes” _builder_version=”4.4.8″ text_text_shadow_horizontal_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength=”text_text_shadow_style,%91object Object%93″ text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength=”link_text_shadow_style,%91object Object%93″ link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength=”header_text_shadow_style,%91object Object%93″ header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

    O papel dos pacientes<\/strong><\/h2>\n

     <\/p>\n

    Para a Associa\u00e7\u00e3o Internacional de Organiza\u00e7\u00f5es de Pacientes (IAPO), os pacientes devem estar cientes da import\u00e2ncia desses medicamentos e do que significa ser acess\u00edvel. A IAPO considera que os pacientes devem ser informados sobre as diferen\u00e7as com evid\u00eancias cient\u00edficas atualizadas. No entanto, ainda \u00e9 necess\u00e1rio muito trabalho com os grupos de pacientes para que tenham acesso \u00e0s informa\u00e7\u00f5es necess\u00e1rias. A Coaliz\u00e3o de Grupos de Pacientes Contra o C\u00e2ncer considera necess\u00e1ria uma educa\u00e7\u00e3o mais completa para gerar defensores de tratamentos que melhorem o conhecimento sobre os biossimilares como um tratamento eficaz e, ao mesmo tempo, auxiliem pacientes e profissionais de sa\u00fade na tomada de decis\u00e3o para inclus\u00e3o desses medicamentos em tratamentos.<\/p>\n

     <\/p>\n

    [\/et_pb_text][et_pb_image _builder_version=”4.4.8″ src=”https:\/\/ideasbr.llorenteycuenca.com\/wp-content\/uploads\/sites\/8\/2021\/08\/web_biologicos_5.png” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″ align=”center” \/][et_pb_text admin_label=”La necesidad de contar con sistemas de salud sostenibles” _builder_version=”4.4.8″ text_text_shadow_horizontal_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength=”text_text_shadow_style,%91object Object%93″ text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength=”link_text_shadow_style,%91object Object%93″ link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength=”header_text_shadow_style,%91object Object%93″ header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

    \u00a0<\/h2>\n

    A necessidade de sistemas de sa\u00fade sustent\u00e1veis<\/strong><\/h2>\n

     <\/p>\n

    O surto de Covid19 suscitou a necessidade urgente de conseguir uma reorienta\u00e7\u00e3o dos sistemas de sa\u00fade para uma melhor distribui\u00e7\u00e3o de recursos humanos, maior investimento p\u00fablico que gere mecanismos que garantam a efici\u00eancia e uma revis\u00e3o dos esquemas reguladores que permitem uma avalia\u00e7\u00e3o aprofundada de alternativas e a ado\u00e7\u00e3o de novos esquemas.<\/p>\n

    A gest\u00e3o da sa\u00fade \u00e9 finalmente percebida pelos governos como a pedra angular da vida e se torna um desafio para os Estados e diferentes atores que buscam construir modelos sustent\u00e1veis que visem otimizar recursos, na l\u00f3gica do custo. Efici\u00eancia, mas com resultados que protejam a vida e gerar maior cobertura de sa\u00fade. Nesse contexto, os biossimilares ou biof\u00e1rmacos representam uma alternativa para muitos pacientes. Alguns sistemas de sa\u00fade j\u00e1 os incorporaram em seus esquemas de tratamento depois que ag\u00eancias regulat\u00f3rias como a FDA, a EMA e outras ao redor do mundo aprovaram este tipo de biof\u00e1rmaco para tratar doen\u00e7as como c\u00e2ncer, doen\u00e7a de Crohn, colite ulcerativa, artrite reumat\u00f3ide e psor\u00edase, entre outras condi\u00e7\u00f5es.<\/p>\n

    \u00c9 urgente uma avalia\u00e7\u00e3o aprofundada do valor terap\u00eautico dos medicamentos biol\u00f3gicos inovadores, bem como da seguran\u00e7a e acessibilidade dos biossimilares, uma vez que permitem combater as doen\u00e7as degenerativas e beneficiar um maior n\u00famero de doentes.<\/p>\n

     <\/p>\n

    [\/et_pb_text][et_pb_text admin_label=”Desaf\u00edos para la adopci\u00f3n de biol\u00f3gicos y biosimilares” _builder_version=”4.4.8″ text_text_shadow_horizontal_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength=”text_text_shadow_style,%91object Object%93″ text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength=”link_text_shadow_style,%91object Object%93″ link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength=”header_text_shadow_style,%91object Object%93″ header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

    Desafios para ado\u00e7\u00e3o de produtos biol\u00f3gicos e biossimilares<\/strong><\/h2>\n

     <\/p>\n

    Os desafios para a ado\u00e7\u00e3o de produtos biol\u00f3gicos e biossimilares continuam e incluem a falta de educa\u00e7\u00e3o voltada para pagadores e pacientes, bem como regulamenta\u00e7\u00e3o que incentive a inova\u00e7\u00e3o e reconhe\u00e7a o valor de ambas as op\u00e7\u00f5es. Permanecem receios infundados em rela\u00e7\u00e3o \u00e0 efic\u00e1cia e seguran\u00e7a, al\u00e9m de outros problemas decorrentes do custo dos medicamentos, do acesso dos pacientes aos mesmos e de sua inclus\u00e3o nos formul\u00e1rios.<\/p>\n

    Os dois grandes desafios s\u00e3o resumidos em:<\/p>\n

    1. Regula\u00e7\u00e3o:<\/strong> Apesar do grande avan\u00e7o na regulamenta\u00e7\u00e3o, a homologa\u00e7\u00e3o \u00e9 necess\u00e1ria para que na maioria dos pa\u00edses os biossimilares ou biocompar\u00e1veis sejam uma op\u00e7\u00e3o para os pacientes e os benef\u00edcios dos biol\u00f3gicos inovadores sejam reconhecidos pelo valor que fornecem e n\u00e3o pelo pre\u00e7o. A Uni\u00e3o Europeia \u00e9 um exemplo porque aprovou mais biossimilares do que outros pa\u00edses e tem a regulamenta\u00e7\u00e3o adequada que avalia um biol\u00f3gico de refer\u00eancia e um biossimilar com o mesmo rigor cient\u00edfico.<\/p>\n

    As autoridades reguladoras aplicam o mesmo rigor cient\u00edfico para avaliar as duas alternativas, portanto, se for um medicamento aprovado por autoridades regulat\u00f3rias, sua efic\u00e1cia e seguran\u00e7a s\u00e3o garantidas, no entanto, a narrativa n\u00e3o \u00e9 clara, por isso \u00e9 necess\u00e1rio elabor\u00e1-la para dar confian\u00e7a e seguran\u00e7a a m\u00e9dicos, pacientes, formuladores de pol\u00edticas p\u00fablicas e pagadores, pois existe uma tend\u00eancia a acreditar que algo mais acess\u00edvel pode ser de baixa qualidade.<\/p>\n

    2. Educa\u00e7\u00e3o:<\/strong> Apesar do fato de haver 15 anos de experi\u00eancia na Europa e evid\u00eancias cient\u00edficas de que n\u00e3o h\u00e1 diferen\u00e7a significativa ou efeito colateral entre o biol\u00f3gico de refer\u00eancia e o biossimilar, a falta de educa\u00e7\u00e3o persiste na maioria dos pa\u00edses, portanto, os fabricantes e as autoridades reguladoras s\u00e3o obrigados a se comunicar mais amplamente os benef\u00edcios dessas alternativas bioterap\u00eauticas, de modo que sejam consideradas mais uma op\u00e7\u00e3o no arsenal do m\u00e9dico para tratar pacientes com doen\u00e7as devastadoras, e representem uma rentabilidade para os sistemas de sa\u00fade, por reduzir significativamente os custos, sem abrir m\u00e3o de tratamentos inovadores que contribuem a avan\u00e7os significativos e inovadores na luta contra doen\u00e7as graves.<\/p>\n

     <\/p>\n

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    \u00a0<\/h2>\n

    Como impulsionar o uso de produtos biol\u00f3gicos e biossimilares<\/strong><\/h2>\n

     <\/p>\n

    Seis fatores para impulsionar o maior uso de produtos biol\u00f3gicos e biossimilares e alavancar o posicionamento da ind\u00fastria biofarmac\u00eautica.<\/strong><\/h3>\n

     <\/p>\n

    1. Construindo confian\u00e7a: <\/strong>As expectativas em rela\u00e7\u00e3o \u00e0 inova\u00e7\u00e3o, ao acesso a novos medicamentos e \u00e0 capacidade de reagir a amea\u00e7as \u00e0 sa\u00fade p\u00fablica mudaram significativamente, \u00e9 necess\u00e1rio um novo modelo de relacionamento que gere confian\u00e7a e mantenha o valor da inova\u00e7\u00e3o farmacol\u00f3gica para enfrentar os problemas de sa\u00fade e que envolva todos os participantes na decis\u00e3o -fazer para incentivar o uso de drogas biol\u00f3gicas. Os biol\u00f3gicos representam uma mudan\u00e7a de paradigma no tratamento de doen\u00e7as e os biossimilares uma possibilidade de ampliar o acesso a medicamentos de alta tecnologia que melhoram a qualidade de vida dos pacientes e impedem o avan\u00e7o das doen\u00e7as degenerativas. A resposta do setor determinar\u00e1 sua licen\u00e7a para operar.<\/p>\n

    2. Narrativa de acordo com o perfil do p\u00fablico: <\/strong>\u00c9 normal que existam diferentes perspectivas em torno do uso de medicamentos inovadores ou do uso de medicamentos biossimilares e isso depende muito da fonte de informa\u00e7\u00e3o. O importante para a ind\u00fastria biofarmac\u00eautica \u00e9 entender o ambiente p\u00f3s-covid19 onde governos e outros provedores de servi\u00e7os de sa\u00fade podem estar sob press\u00e3o para cortar or\u00e7amentos; Os m\u00e9dicos tamb\u00e9m buscar\u00e3o a melhor op\u00e7\u00e3o terap\u00eautica para os pacientes e ter\u00e3o um papel na tomada de decis\u00f5es sobre a melhor op\u00e7\u00e3o para o tratamento de sua doen\u00e7a. Diante desse cen\u00e1rio, faz-se necess\u00e1ria uma narrativa que considere n\u00e3o apenas os resultados cient\u00edficos, mas tamb\u00e9m a disponibilidade para aceitar novas alternativas, e para isso \u00e9 preciso adaptar a narrativa para que fique de acordo com a realidade de cada p\u00fablico. Al\u00e9m disso, todas as informa\u00e7\u00f5es sobre medicamentos inovadores, biol\u00f3gicos e biossimilares est\u00e3o dispon\u00edveis, amplamente divulgadas em diversos canais e evitam-se lacunas de informa\u00e7\u00e3o. As novas tecnologias permitem um maior alcance e melhor penetra\u00e7\u00e3o das mensagens.<\/p>\n

    3. Humaniza\u00e7\u00e3o da informa\u00e7\u00e3o: <\/strong>As empresas farmac\u00eauticas e os m\u00e9dicos falam sobre ci\u00eancia, mas para os pacientes e outros p\u00fablicos, os termos cient\u00edficos n\u00e3o se entendem ou se entendem pouco. \u00c9 necess\u00e1rio ver os benef\u00edcios terap\u00eauticos nos pacientes e ver como os medicamentos biol\u00f3gicos e biossimilares melhoram a qualidade de vida, curam doen\u00e7as e salvam vidas; Contar a hist\u00f3ria na perspectiva do paciente ajuda a humanizar a comunica\u00e7\u00e3o e gera empatia e interesse em aprender mais.<\/p>\n

    4. Ecossistema digital: maior acesso \u00e0 informa\u00e7\u00e3o: <\/strong>\u00c9 importante que os m\u00e9dicos informem os pacientes sobre as duas alternativas, para que haja evid\u00eancias cient\u00edficas e informa\u00e7\u00f5es adequadas para uma decis\u00e3o compartilhada sobre o tipo de tratamento adequado a cada caso. A decis\u00e3o deve ser baseada na recomenda\u00e7\u00e3o do m\u00e9dico e o paciente deve fazer parte da tomada de decis\u00e3o. Um ecossistema digital que orienta o paciente e inclui v\u00e1rias plataformas de engajamento pode ser uma alternativa para obter as informa\u00e7\u00f5es que o movem para a a\u00e7\u00e3o. A comunica\u00e7\u00e3o digital, os computadores e os dispositivos m\u00f3veis tornaram-se parte fundamental do nosso dia a dia e a comunica\u00e7\u00e3o deve se adaptar para aproveitar os novos canais, formatos e conte\u00fados.<\/p>\n

    \u00a05. <\/strong>Transpar\u00eancia: Posi\u00e7\u00f5es claras e comunica\u00e7\u00e3o constante: <\/strong>\u00c9 necess\u00e1ria transpar\u00eancia no manuseio das informa\u00e7\u00f5es, tanto das empresas fabricantes quanto dos \u00f3rg\u00e3os reguladores, com posicionamentos claros e comunica\u00e7\u00e3o constante que gere confian\u00e7a e credibilidade e que permita a m\u00e9dicos e pacientes adotarem o uso de alternativas bioterap\u00eauticas adequadas a cada caso.<\/p>\n

    6. Porta-vozes preparados e pr\u00f3ximos: <\/strong>A import\u00e2ncia de ter um bom porta-voz \u00e9 not\u00f3ria, por\u00e9m, nesses casos \u00e9 importante que al\u00e9m de conhecer os aspectos m\u00e9dicos e cient\u00edficos, as empresas tenham porta-vozes treinados que gerem empatia e proximidade, humanizando a conversa e transmitindo emo\u00e7\u00f5es que movam a a\u00e7\u00e3o em benef\u00edcio dos pacientes.<\/p>\n

     <\/p>\n

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    \u201cNecessitamos de um sistema de sa\u00fade que garanta o acesso, a universalidade, a equidade e, acima de tudo, a sustentabilidade.\u201d<\/h2>\n

    [\/et_pb_text][et_pb_text admin_label=”Conclusi\u00f3n” _builder_version=”4.4.8″ text_text_shadow_horizontal_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length=”text_text_shadow_style,%91object Object%93″ text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength=”text_text_shadow_style,%91object Object%93″ text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length=”link_text_shadow_style,%91object Object%93″ link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength=”link_text_shadow_style,%91object Object%93″ link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength=”ul_text_shadow_style,%91object Object%93″ ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength=”ol_text_shadow_style,%91object Object%93″ ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength=”quote_text_shadow_style,%91object Object%93″ quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length=”header_text_shadow_style,%91object Object%93″ header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength=”header_text_shadow_style,%91object Object%93″ header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength=”header_2_text_shadow_style,%91object Object%93″ header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength=”header_3_text_shadow_style,%91object Object%93″ header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength=”header_4_text_shadow_style,%91object Object%93″ header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength=”header_5_text_shadow_style,%91object Object%93″ header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength=”header_6_text_shadow_style,%91object Object%93″ header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″]<\/p>\n

    Conclus\u00e3o<\/strong><\/h2>\n

    \u00a0<\/p>\n

    Produtos biol\u00f3gicos inovadores representam avan\u00e7os significativos na luta contra doen\u00e7as devastadoras, como as imunol\u00f3gicas, c\u00e2ncer e outras condi\u00e7\u00f5es cr\u00f4nicas e degenerativas. Para que os biol\u00f3gicos inovadores sejam reconhecidos pelo seu valor, e n\u00e3o pelo seu pre\u00e7o, \u00e9 necess\u00e1ria uma ampla estrat\u00e9gia de comunica\u00e7\u00e3o que ligue todos os envolvidos e que gere interesse na contribui\u00e7\u00e3o da inova\u00e7\u00e3o e a incentive, pois contribui para o desenvolvimento de melhores tratamentos, com menos efeitos colaterais.<\/p>\n

    Por sua vez, os medicamentos biossimilares s\u00e3o uma op\u00e7\u00e3o para que cada vez mais pacientes tenham acesso \u00e0s terapias biol\u00f3gicas avan\u00e7adas. Para isso, pagadores, m\u00e9dicos e pacientes s\u00e3o obrigados a ter todas as evid\u00eancias cient\u00edficas e informa\u00e7\u00f5es necess\u00e1rias para tomar decis\u00f5es baseadas em benef\u00edcios terap\u00eauticos, seguran\u00e7a, efic\u00e1cia e que visem a sustentabilidade dos sistemas de sa\u00fade. Devido \u00e0s recentes amea\u00e7as \u00e0 sa\u00fade p\u00fablica, que todos conhecemos, necessitamos – hoje mais do que antes – de um sistema de sa\u00fade que garanta o acesso, a universalidade, a equidade e, acima de tudo, a sustentabilidade.<\/p>\n

    Um programa de comunica\u00e7\u00e3o para ambas as alternativas deve ser baseado em evid\u00eancias cient\u00edficas, desenvolver uma narrativa de acordo com cada p\u00fablico que destaque os benef\u00edcios para os pacientes e, por fim, a equipe de consultoria deve ter ampla experi\u00eancia e conhecimento do setor de sa\u00fade, da ind\u00fastria farmac\u00eautica e do valor das terapias, caso contr\u00e1rio, a Comunica\u00e7\u00e3o, que \u00e9 cr\u00edtica nestes casos, n\u00e3o contribuir\u00e1 ou contribuir\u00e1 muito pouco, para o crescimento do uso de terapias que sem d\u00favida melhoram e salvam vidas.<\/p>\n

    \u00a0<\/p>\n

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