| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| 1.48 MB | Adobe PDF |
Authors
Advisor(s)
Abstract(s)
A presente dissertação foi desenvolvida no âmbito da conclusão do Mestrado Integrado
em Ciências Farmacêuticas e encontra-se dividida em dois capítulos: Capítulo 1, com a
descrição das aptidões adquiridas durante o estágio curricular em Farmácia Comunitária,
e, Capítulo 2, com a apresentação do trabalho de investigação.
O Capítulo 1 consiste numa breve caraterização e organização da farmácia comunitária,
bem como numa descrição de todos os processos do circuito do medicamento, desde o seu
aprovisionamento e armazenamento, à dispensa ao utente. Resume também a experiência,
as competências e conhecimentos obtidos e, ainda, as atividades desenvolvidas durante o
estágio em farmácia comunitária que decorreu entre 8 de fevereiro e 25 de junho de 2021,
na farmácia Sena Padez, no Fundão.
O Capítulo 2, referente à componente de Investigação, compreende uma coletânea e
análise dos medicamentos biológicos comercializados em Portugal e no resto da Europa,
até dezembro de 2022.
Os medicamentos biológicos, também denominados de biofármacos ou biofarmacêuticos,
são moléculas cuja substância ativa é produzida ou extraída de uma fonte biológica, como
células animais, células vegetais ou microrganismos. Estes produtos podem ser utilizados
para diagnosticar, prevenir, tratar ou curar doenças ou condições humanas para as quais
não existe uma resposta com medicamentos tradicionais produzidos por síntese química.
A primeira parte deste trabalho de revisão apresenta a contextualização do tema e dos
conceitos mais importantes, de modo a auxiliar a compreensão dos tópicos seguintes.
Numa segunda parte, são descritas duas classes de medicamentos biológicos e respetivos
biofármacos, nomeadamente os fatores de coagulação e os produtos baseados em
anticorpos, tanto comercializados como não comercializados em Portugal, mas disponíveis
no resto da Europa. Destaca-se, ainda, aqueles que não apresentam medicamento
biológico alternativo no mercado português. No final do trabalho, em anexo, encontram-se
descritos todos os medicamentos biológicos aprovados em Portugal e no resto da Europa.
Foram analisadas, através da base de dados da Agência Europeia do Medicamento (EMA
do inglês European Medicine Agency) e do Infomed, dez categorias de biofármacos,
concretamente: fatores de coagulação, anticorpos monoclonais (mAb)s, hormonas, fatores de crescimento, citocinas, vacinas, enzimas, proteínas de fusão, medicamentos de terapia
celular e medicamentos de terapia genética e, por fim, outros produtos recombinantes.
O objetivo deste trabalho visa detetar padrões de oferta e de procura ao longo dos anos,
averiguar quais são os medicamentos disponíveis no mercado europeu e quais os que são
efetivamente, comercializados em Portugal. Além disso, tem, também, o propósito da
compilação e uniformização da informação existente neste sentido, podendo ser utilizado
como instrumento de consulta aos profissionais de saúde.
Nas últimas décadas, a investigação e a inovação na área da biotecnologia farmacêutica
possibilitaram o desenvolvimento de um grande número de biofármacos cada vez mais
específicos para determinadas doenças. Dos mais de 300 medicamentos biológicos
aprovados na Europa, os produtos baseados em mAbs, os fatores de coagulação, as
hormonas e os fatores de crescimento são as classes de medicamentos com mais
medicamentos aprovados. Os biossimilares representam mais de 20% do mercado
biológico europeu. O mercado português tem, aproximadamente, a mesma percentagem
de biossimilares, contudo, apresenta cerca de dois terços dos biofármacos aprovados pela
EMA. Tal pode dever-se a vários fatores, principalmente, a procura deste tipo de produtos
e os preços dos mesmos que, após avaliação, podem ser considerados proibitivos para o
orçamento disponível no serviço nacional de saúde. Apesar destes desafios, Portugal
desenvolveu protocolos para aplicar aos medicamentos que não têm aprovação de
comercialização, tornando-os, assim, acessíveis a doentes que necessitam de tratamentos
que, de outra forma, não poderiam ser efetuados.
This review was developed within the framework of completing the Integrated Master in Pharmaceutical Sciences and is divided into two chapters: Chapter 1, with the description of the skills acquired during the curricular internship in Community Pharmacy, and Chapter 2, with the presentation of the investigation work. Chapter 1 consists of a brief characterization and organization of the community pharmacy, as well as a description of all the processes of the medication circuit, from its supply and storage to dispensing to the user. It also summarizes the experience, skills, and knowledge obtained, as well as the activities carried out during the internship in community pharmacy, which took place between February 8 and June 25, 2021, at the Sena Padez pharmacy, in Fundão. Chapter 2, referring to the Research component, comprises a collection and analysis of biological medicines marketed Portugal and in the rest of Europe, until December 2022. Biological medicines, also named biopharmaceuticals, are molecules whose active substance is produced or extracted from a biological source, such as animal cells, plant cells or microorganisms. They are used to diagnose, prevent, treat or cure human diseases or conditions that could not be effectively treated with traditional medicines produced by chemical synthesis. The first part of this revision work presents the contextualization of the subject and the main related concepts to facilitate the understanding of the following content. In a second part, two classes of biological medicines and corresponding biopharmaceuticals, namely the clotting factors and antibody-based products, that are marketed or not marketed in Portugal but available in the rest of Europe are described,. Also worth mentioning are those for which there is no alternative biological medicine on the Portuguese market. At the end of the work, in the appendix, there are presented all the biological medicines approved in Portugal and the rest of Europe. Ten categories of biopharmaceuticals were analysed, through the database of the European Medicines Agency (EMA) and Infomed, specifically: clotting factors, monoclonal antibodies, hormones, growth factors, cytokines, vaccines, enzymes, fusion proteins and cell therapy drugs, gene therapy drugs and other recombinant products. This document aims to detect patterns of supply and demand over the years to figure out which medicines are available on the European market and which ones are, effectively marketed in Portugal. In addition, it also has the purpose of standardizing existing information in this regard and can be used as a consultation tool for health professionals. In recent decades, the search for innovation in the field of pharmaceutical biotechnology has allowed the development of a large number of biopharmaceuticals that are increasingly specific to several diseases. Of the more than 300 biological medicines approved in Europe, products based on mAbs, clotting factors, hormones and growth factors are the classes with the most approved products. Biosimilars account for more than 20% of the European biologics market. The Portuguese market has about the same percentage of biosimilars, but has about two-thirds of the biopharmaceuticals approved by the EMA. This may be due to several factors, most notably the market demand for these products and their prices, which may be prohibitively expensive for the national healthcare budget after evaluation. Despite these challenges, Portugal has developed protocols for biological medicines that do not have regulatory approval, making them available to patients for treatments that could not otherwise be provided.
This review was developed within the framework of completing the Integrated Master in Pharmaceutical Sciences and is divided into two chapters: Chapter 1, with the description of the skills acquired during the curricular internship in Community Pharmacy, and Chapter 2, with the presentation of the investigation work. Chapter 1 consists of a brief characterization and organization of the community pharmacy, as well as a description of all the processes of the medication circuit, from its supply and storage to dispensing to the user. It also summarizes the experience, skills, and knowledge obtained, as well as the activities carried out during the internship in community pharmacy, which took place between February 8 and June 25, 2021, at the Sena Padez pharmacy, in Fundão. Chapter 2, referring to the Research component, comprises a collection and analysis of biological medicines marketed Portugal and in the rest of Europe, until December 2022. Biological medicines, also named biopharmaceuticals, are molecules whose active substance is produced or extracted from a biological source, such as animal cells, plant cells or microorganisms. They are used to diagnose, prevent, treat or cure human diseases or conditions that could not be effectively treated with traditional medicines produced by chemical synthesis. The first part of this revision work presents the contextualization of the subject and the main related concepts to facilitate the understanding of the following content. In a second part, two classes of biological medicines and corresponding biopharmaceuticals, namely the clotting factors and antibody-based products, that are marketed or not marketed in Portugal but available in the rest of Europe are described,. Also worth mentioning are those for which there is no alternative biological medicine on the Portuguese market. At the end of the work, in the appendix, there are presented all the biological medicines approved in Portugal and the rest of Europe. Ten categories of biopharmaceuticals were analysed, through the database of the European Medicines Agency (EMA) and Infomed, specifically: clotting factors, monoclonal antibodies, hormones, growth factors, cytokines, vaccines, enzymes, fusion proteins and cell therapy drugs, gene therapy drugs and other recombinant products. This document aims to detect patterns of supply and demand over the years to figure out which medicines are available on the European market and which ones are, effectively marketed in Portugal. In addition, it also has the purpose of standardizing existing information in this regard and can be used as a consultation tool for health professionals. In recent decades, the search for innovation in the field of pharmaceutical biotechnology has allowed the development of a large number of biopharmaceuticals that are increasingly specific to several diseases. Of the more than 300 biological medicines approved in Europe, products based on mAbs, clotting factors, hormones and growth factors are the classes with the most approved products. Biosimilars account for more than 20% of the European biologics market. The Portuguese market has about the same percentage of biosimilars, but has about two-thirds of the biopharmaceuticals approved by the EMA. This may be due to several factors, most notably the market demand for these products and their prices, which may be prohibitively expensive for the national healthcare budget after evaluation. Despite these challenges, Portugal has developed protocols for biological medicines that do not have regulatory approval, making them available to patients for treatments that could not otherwise be provided.
Description
Keywords
Anticorpos
Monoclonais Biobetters Biossimilares Citocinas Enzimas Fatores de Coagulação Fatores de Crescimento Hormonas Medicamentos Biológicos Mercado Europeu Mercado Português Proteínas de
Fusão Terapia Celular Terapia Genética Vacinas