Anvisa concede à Bionovis o registro do 1º medicamento biológico nacional

Da Redação

A Anvisa concedeu o primeiro registro de um medicamento biológico que terá produção 100% nacional. O Etanercepte, produto indicado ao tratamento da artrite reumatoide e outras doenças graves que afetam as articulações, será produzido a partir do segundo semestre do ano que vem pelo laboratório brasileiro Bionovis, empresa que é uma joint venture formada pelos laboratórios farmacêuticos nacionais Aché, EMS, Hypermarcas e União Química.

O Etanercepte, que hoje é oferecido gratuitamente por meio do programa de alto custo do Ministério da Saúde, é fabricado pela Boehringer Ingelheim Pharma KG, da Alemanha, importado e distribuído pelos laboratórios Wyeth-Whitehall sob o nome comercial de “Enbrel”. No ano passado, o prazo de proteção patentária do produto expirou, possibilitando assim a produção de cópias do produto, em mecanismo jurídico idêntico ao dos genéricos.

O medicamento produzido pela Bionovis deverá custar 50% menos que o medicamento hoje importado, permitindo uma economia significativa ao Ministério da Saúde. As cifras podem chegar a R$ 726 milhões em um período de 5 anos, tempo determinado em contrato entre o Ministério da Saúde e a Bionovis para a oferta do medicamento.

Somente em 2012, o Ministério da Saúde gastou R$ 364 milhões na compra para suprir a demanda. O contrato entre a empresa e o governo ainda prevê parceira de transferência de tecnologia entre a companhia e os laboratórios públicos Instituto Vital Brasil e Biomanguinhos.

De acordo com o Ministério da Saúde, o Etanercepte é oferecido a 16.431 pacientes do SUS (Sistema Único de Saúde), nas apresentações 25mg e 50mg, e lista entre as maiores despesas individuais do Ministério da Saúde que, com a economia, poderá investir em outras áreas ou na ampliação da oferta de mais medicamentos. Só em 2012, o Ministério da Saúde gastou R$ 364 milhões na compra para suprir a demanda. Com o registro da Anvisa, os laboratórios têm autorização para construir no Brasil uma fábrica para começar os ensaios clínicos com o medicamento. Para a comercialização do produto, a Agência deve conceder um segundo registro.

Para o presidente executivo da Bionovis, Odnir Finotti, a produção do Etanercepte no Brasil se inicia entre 12 e 18 meses. Serão investidos cerca de R$ 30 milhões em estudos clínicos. “A concessão do registro é um passo importante para a consolidação do mercado de biotecnologia farmacêutica no Brasil. Além de abrir a possibilidade de um salto tecnológico importante para a indústria nacional, reduzindo o déficit da nossa balança comercial de medicamentos, permitirá que o Ministério da Saúde continue oferecendo medicamentos seguros e eficazes no tratamento de doenças graves, por um preço muito mais vantajoso para o governo”, explica Finotti.

A opinião é compartilhada pelo secretário de Ciência, Tecnologia e Inovação (SCTIE), Carlos Gadelha, do Ministério da Saúde. “Este é um grande passo no caminho da autonomia da indústria brasileira no campo da saúde. Ao conquistar a independência dos produtos importados, o Brasil reduz seus custos e pode ampliar o acesso da população a um roll cada vez maior de medicamentos”, afirma em nota do Ministério da Saúde.

Fonte: Snif Brasil



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