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Publication
Medicamentos biológicos em Portugal
| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| PPG_33605 | 1.26 MB | Adobe PDF |
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Abstract(s)
Os medicamentos biológicos ou biológicos têm origem em processos biotecnológicos, podendo a sua produção variar de acordo com a molécula em questão, o que faz destes processos mais complexos do que os usados na produção dos medicamentos de síntese. Isto deve-se ao facto de se usarem organismos vivos e substratos complexos que envolvem inúmeras etapas e tecnologias de ponta até à obtenção do produto final.
Os medicamentos biológicos são atualmente uma das maiores fontes de inovação e desenvolvimento da indústria farmacêutica, revolucionando diversas terapias para doenças que até então não tinham tratamento ou que recorriam a terapias convencionais ineficazes. Estes medicamentos permitem diagnosticar, prevenir, tratar e/ou curar doenças e condições médicas complexas, como o tratamento de doenças raras, oncológicas, hematológicas, reumatológicas, entre outras.
A primeira parte deste trabalho de revisão tem como finalidade a contextualização do tema dos medicamentos biológicos e de todos os conceitos relacionados. De seguida, são descritas as etapas cruciais do desenvolvimento dos medicamentos biológicos, desde a sua produção à sua comercialização e dispensa. Por fim, são descritas algumas das classes de medicamentos biológicos aprovados e comercializados em Portugal e as suas respetivas aplicações clínicas, com o objetivo de dar a conhecer um pouco mais destes e as opções existentes no país.
O número de medicamentos biológicos aprovados em Portugal é extenso e muito promissor, encontrando-se em constante atualização. Dentro das classes abordadas, as com maior número de medicamentos aprovados são as dos fatores de crescimento, das hormonas e dos fatores de coagulação. No entanto, muitos outros estão aprovados e comercializados em Portugal pelo Infarmed.
The biological medicines or biologicals originate from biotechnological processes, and their production may vary according to the molecule in question, which makes these processes more complex than those used in the production of synthetic medicines. This is due to the fact that live organisms and complex substrates are used that involve several stages and advanced technologies until obtaining the final product. These drugs allow to diagnose, prevent, treat and/or cure complex medical conditions and diseases, such as the treatment of oncological, hematological, rheumatological and rare diseases, among others. Biologicals are currently one of the biggest sources of innovation and development in the pharmaceutical industry, revolutionizing several therapies for diseases that until then had no treatment or that resorted to ineffective conventional therapies. These medicines allow diagnosing, preventing, treating and/or curing complex medical conditions, including the treatment of oncological, hematological, rheumatological and rare diseases, among others. The first part of this review aims to contextualize the theme of the biological medicines and all related concepts. Next, the crucial stages of the development of biological medicines are described, from their production to commercialization and dispensation. Finally, some of the existing classes of biological medicines approved and marketed in Portugal are described, as well as their respective clinical applications, with the objective of making known these and the options existing in the country. The number of biological medicines approved in Portugal is extensive and very promising, being constantly updated. Within the developed classes, those with the highest number of approved drugs are growth factors, hormones and clotting factors. However, many others are approved and marketed in Portugal by Infarmed.
The biological medicines or biologicals originate from biotechnological processes, and their production may vary according to the molecule in question, which makes these processes more complex than those used in the production of synthetic medicines. This is due to the fact that live organisms and complex substrates are used that involve several stages and advanced technologies until obtaining the final product. These drugs allow to diagnose, prevent, treat and/or cure complex medical conditions and diseases, such as the treatment of oncological, hematological, rheumatological and rare diseases, among others. Biologicals are currently one of the biggest sources of innovation and development in the pharmaceutical industry, revolutionizing several therapies for diseases that until then had no treatment or that resorted to ineffective conventional therapies. These medicines allow diagnosing, preventing, treating and/or curing complex medical conditions, including the treatment of oncological, hematological, rheumatological and rare diseases, among others. The first part of this review aims to contextualize the theme of the biological medicines and all related concepts. Next, the crucial stages of the development of biological medicines are described, from their production to commercialization and dispensation. Finally, some of the existing classes of biological medicines approved and marketed in Portugal are described, as well as their respective clinical applications, with the objective of making known these and the options existing in the country. The number of biological medicines approved in Portugal is extensive and very promising, being constantly updated. Within the developed classes, those with the highest number of approved drugs are growth factors, hormones and clotting factors. However, many others are approved and marketed in Portugal by Infarmed.
Description
Keywords
Medicamento biológico Medicamento biossimilar Citocinas Fatores de crescimento Hormonas Hemoderivados Enzimas terapêuticas Biobetters Biological medicine Biosimilar medicine Cytokines Growth factors Hormones Blood products Therapeutic enzymes Biobetters