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Bloco latino-americano da ASBM participa de fórum sobre biossimilares no Brasil
  • Latin America - español


News provided by

Alliance for Safe Biologic Medicines

Sep 28, 2016, 09:38 ET

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SÃO PAULO, 28 de setembro de 2016 /PRNewswire/ -- O bloco latino-americano da Alliance for Safe Biologic Medicines (ASBM) e da Global Colon Cancer Association (GCCA) participou hoje de um fórum sobre medicamentos biológicos e biossimilares em São Paulo, Brasil. O bloco é composto de oito organizações de pacientes representando diversos grupos de doenças, incluindo as várias formas de câncer, hepatite e doenças neurológicas. O fórum, intitulado "O que os pacientes precisam saber sobre medicamentos biológicos e biossimilares", foi realizado como parte do 3o. Congresso Brasileiro Todos Juntos Contra o Câncer e foi assistido por mais de 300 porta-vozes de pacientes, principalmente da América Latina.

Andrew Spiegel, diretor executivo da GCCA e membro fundador da ASBM, coordenou a discussão de duas horas sobre tentativas biossimilares de criar versões mais baratas de medicamentos biológicos que tratam doenças graves como artrite reumatoide, psoríase e diversos tipos de câncer. Ao contrário das versões genéricas de medicamentos químicos, os biossimilares não são cópias exatas dos medicamentos originais, são somente "semelhantes". Estas diferenças podem criar efeitos inesperados em pacientes, incluindo respostas imunológicas inesperadas. As políticas em relação a sua utilização devem refletir essas preocupações; como o Sr. Spiegel disse: "Os biossimilares são uma grande promessa para os pacientes da América Latina, oferecendo-lhes novas opções de menor custo, mas para poder oferecer estes benefícios, paciente e médicos precisam estar seguros quanto a sua segurança e eficácia".

O médico Valderílio Azevedo, reumatologista da Universidade Federal do Paraná e o médico Harry L Gewanter, presidente da ASBM, mostraram a perspectiva do médico quanto aos biossimilares. O Dr. Gewanter compartilhou os resultados de uma pesquisa com 399 médicos prescritores de medicamentos biológicos de quatro países da América Latina: Argentina, Brasil, Colômbia e México. A ASBM recentemente apresentou esses dados no XIX Congresso da Liga Pan-Americana de Associações de Reumatologia na cidade do Panamá, Panamá em abril; e no 6o. Fórum Latino-Americano de Biossimilares em Brasília, Brasil, em junho.

A pesquisa revelou a necessidade de uma nomenclatura clara para todos os produtos biológicos, incluindo biossimilares: 57% dos entrevistados se referem a um medicamento biológico exclusivamente pela sua denominação comum em um prontuário de paciente (o que poderia resultar em pacientes recebendo o medicamento errado). Além disso, cerca de 28% usa a denominação comum exclusivamente ao relatar eventos adversos (o que poderia resultar na atribuição a um medicamento errado).

A Organização Mundial de Saúde (OMS), que emite denominações comuns internacionais, propôs-se a diferenciar os medicamentos similares um do outro pelo uso de um qualificador biológico (QB), um único código de quatro letras adicionadas ao nome de uma raiz compartilhada. A pesquisa revelou que 94% dos entrevistados considerou o QB "útil para ajudar a garantir que seus pacientes recebem o medicamento certo".

Carolina Cohen, diretora da ABRALE, Associação Brasileira de Linfoma e Leucemia, integrante da ASBM que idealizou e organizou a conferência maior, enfatizou a necessidade de pacientes e médicos aprenderem sobre biossimilares e envolverem as autoridades reguladoras. "Atualmente, o nível de proteção aos pacientes da política dos biossimilares varia amplamente de país para país. A ABRALE acredita que pacientes deveriam poder esperar biossimilares seguros e eficazes em qualquer país em que fazem um tratamento. A ASBM trabalha globalmente desde 2010 para ensinar sobre estes medicamentos e promover seu uso seguro".

A Alliance for Safe Biologic Medicines (ASBM) é uma organização composta por diversos grupos ligados à saúde e pessoas, incluindo pacientes, médicos, farmacêuticos, fabricantes de medicamentos inovadores e biossimilares e outros, que trabalham em conjunto para garantir que a segurança do paciente permaneça à frente da discussão sobre a política dos biossimilares.

Para mais informações, entre em contato com:

Michael Reilly
Diretor executivo
Alliance for Safe Biologic Medicines
Telefone: 202-222-8326
E-mail: [email protected]

FONTE Alliance for Safe Biologic Medicines

Related Links

http://www.safebiologics.org

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