Loading...
Publication
Medicamentos biossimilares no tratamento do cancro na UniĆ£o Europeia
Advisor(s)
Abstract(s)
Os medicamentos biossimilares surgiram apĆ³s expirarem as primeiras patentes de medicamentos biolĆ³gicos, tendo sido legislados pela UniĆ£o Europeia em 2005, e sendo definidos como aqueles que, quando produzidos por um novo fabricante, demonstram semelhanƧa com um medicamento biolĆ³gico previamente aprovado, designado medicamento biolĆ³gico de referĆŖncia. Neste sentido, um medicamento biossimilar tem de demonstrar a mesma qualidade, seguranƧa e eficĆ”cia que o medicamento biolĆ³gico original. Esta classe de medicamentos constitui uma alternativa econĆ³mica, jĆ” que dispensa a realizaĆ§Ć£o de alguns estudos dispendiosos, quando comprovado que a sua atividade Ć© semelhante Ć© do medicamento biolĆ³gico de referĆŖncia. Em comparaĆ§Ć£o com os medicamentos genĆ©ricos clĆ”ssicos, o desenvolvimento e fabrico de medicamentos biossimilares Ć© mais complexo e dispendioso, uma vez que a sua eficĆ”cia e seguranƧa tĆŖm de ser confirmadas com dados clĆnicos e/ou prĆ©-clĆnicos.
Na primeira parte deste trabalho sĆ£o descritas as etapas cruciais do desenvolvimento de medicamentos biossimilares, que vĆ£o desde a sua produĆ§Ć£o atĆ© Ć introduĆ§Ć£o no mercado. De seguida, sĆ£o apresentados os medicamentos biossimilares usados no tratamento do cancro na Europa. Nesta Ć”rea, a sua aplicaĆ§Ć£o Ć© notĆ”vel, de forma direta (no tratamento da doenƧa propriamente dita) e de forma indireta (no tratamento de efeitos secundĆ”rios resultantes do tratamento da doenƧa). Em qualquer uma das situaƧƵes, o principal objetivo da utilizaĆ§Ć£o destes medicamentos Ć© aumentar a acessibilidade da populaĆ§Ć£o Ć terapia com medicamentos de origem biolĆ³gica, por se tratar de uma alternativa mais econĆ³mica para os sistemas de saĆŗde e, consequentemente, para o doente.
Biosimilar medicines emerged after expired the first patents of biological medicines. They were legislated by the European Union in 2005, being defined as those which, when produced by a new manufacturer, show a similarity to a previously approved biological medicine, known as the reference biological medicine. In this sense, a biosimilar drug must demonstrate the same quality, safety and efficacy as the original biological drug. This class of drugs is a more affordable alternative, since it does not require a large number of expensive studies, when proved that their activity is similar to those of the reference biological medicine. However, compared to classical generic drugs, the development and manufacture of biosimilar medicinal products is more complex and costly, once their efficacy and safety are confirmed by clinical and / or preclinical data. In the first part of this work are described the crucial stages of the development of biosimilar drugs, since their production until their introduction in the market. Then, are presented the biosimilar medicines that are used in the treatment of cancer in Europe. In this area, its use is noticeable directly (in the treatment of the disease itself) and indirectly (in the treatment of side effects resulting from the treatment of the disease). In both cases, the main goal of the use of these medicines is to increase the access to biological therapy by the general population, since it is a more economical alternative for the health systems and, consequently, for the patient.
Biosimilar medicines emerged after expired the first patents of biological medicines. They were legislated by the European Union in 2005, being defined as those which, when produced by a new manufacturer, show a similarity to a previously approved biological medicine, known as the reference biological medicine. In this sense, a biosimilar drug must demonstrate the same quality, safety and efficacy as the original biological drug. This class of drugs is a more affordable alternative, since it does not require a large number of expensive studies, when proved that their activity is similar to those of the reference biological medicine. However, compared to classical generic drugs, the development and manufacture of biosimilar medicinal products is more complex and costly, once their efficacy and safety are confirmed by clinical and / or preclinical data. In the first part of this work are described the crucial stages of the development of biosimilar drugs, since their production until their introduction in the market. Then, are presented the biosimilar medicines that are used in the treatment of cancer in Europe. In this area, its use is noticeable directly (in the treatment of the disease itself) and indirectly (in the treatment of side effects resulting from the treatment of the disease). In both cases, the main goal of the use of these medicines is to increase the access to biological therapy by the general population, since it is a more economical alternative for the health systems and, consequently, for the patient.
Description
Keywords
Medicamento biossimilar Medicamento biolĆ³gico de referĆŖncia Tratamento do cancro Biosimilar medicine Biologic reference medicine Cancer treatment