The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update

Detalhes bibliográficos
Autor(a) principal: Araújo, Filipe C.
Data de Publicação: 2018
Outros Autores: Sepriano, Alexandre, Teixeira, F., Jesus, D., Rocha, T. M., Martins, Paula Andreia, Tenazinha, C., Cordeiro, A., Mourão, A. F., Silva, C., Vaz, C., Duarte, C., Ponte, C., dos Santos, F. P., Canhão, Helena, Santos, H., Pimentão, J. B., da Silva, J. C., Polido-Pereira, J., Miranda, L. C., Oliveira, M., Saavedra, M. J., Gonçalves, P., Falcão, S., Capela, S., Fonseca, J. E.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://www.scopus.com/inward/record.url?scp=85042565771&partnerID=8YFLogxK
Resumo: Biosimilars are new and more affordable similar versions of previously approved reference biological drugs. Following the approval of the first monoclonal antibody biosimilar in 2013, the Portuguese Society of Rheumatology issued a position paper on the use of biosimilars in rheumatic conditions covering efficacy, safety, extrapolation, interchangeability, substitution and pharmacovigilance. However, as this is a rapidly evolving field, it was felt that the knowledge and evidence gathered since then justified an update of these statements. Literature searches on these issues were performed and the search results were presented and discussed in a national meeting. Portuguese rheumatologists considered that affordability should be taken into consideration when initiating a biological drug, but other factors were equally important. In patients already on reference biological treatment, switch to a more affordable biosimilar is desirable, provided a set of conditions is rigorously met. Automatic substitution is not acceptable and current evidence is insufficient to support interchangeability. Extrapolation of clinical indications is endorsed by Portuguese rheumatologists, and the statements on safety, pharmacovigilance and traceability are in accordance with the previous position paper.
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spelling The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 updateAnkylosing spondylitisAnti-tumor necrosis factor-alpha therapyBiosimilarRheumatoid arthritisRheumatologyBiosimilars are new and more affordable similar versions of previously approved reference biological drugs. Following the approval of the first monoclonal antibody biosimilar in 2013, the Portuguese Society of Rheumatology issued a position paper on the use of biosimilars in rheumatic conditions covering efficacy, safety, extrapolation, interchangeability, substitution and pharmacovigilance. However, as this is a rapidly evolving field, it was felt that the knowledge and evidence gathered since then justified an update of these statements. Literature searches on these issues were performed and the search results were presented and discussed in a national meeting. Portuguese rheumatologists considered that affordability should be taken into consideration when initiating a biological drug, but other factors were equally important. In patients already on reference biological treatment, switch to a more affordable biosimilar is desirable, provided a set of conditions is rigorously met. Automatic substitution is not acceptable and current evidence is insufficient to support interchangeability. Extrapolation of clinical indications is endorsed by Portuguese rheumatologists, and the statements on safety, pharmacovigilance and traceability are in accordance with the previous position paper.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)Centro de Estudos de Doenças Crónicas (CEDOC)RUNAraújo, Filipe C.Sepriano, AlexandreTeixeira, F.Jesus, D.Rocha, T. M.Martins, Paula AndreiaTenazinha, C.Cordeiro, A.Mourão, A. F.Silva, C.Vaz, C.Duarte, C.Ponte, C.dos Santos, F. P.Canhão, HelenaSantos, H.Pimentão, J. B.da Silva, J. C.Polido-Pereira, J.da Silva, J. C.Miranda, L. C.Oliveira, M.Saavedra, M. J.Gonçalves, P.Falcão, S.Capela, S.Fonseca, J. E.2018-03-15T23:18:48Z2018-022018-02-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article10application/pdfhttp://www.scopus.com/inward/record.url?scp=85042565771&partnerID=8YFLogxKeng0303-464XPURE: 3693959http://www.scopus.com/inward/record.url?scp=85042565771&partnerID=8YFLogxKinfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T04:18:09Zoai:run.unl.pt:10362/32618Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:29:54.783066Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update
title The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update
spellingShingle The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update
Araújo, Filipe C.
Ankylosing spondylitis
Anti-tumor necrosis factor-alpha therapy
Biosimilar
Rheumatoid arthritis
Rheumatology
title_short The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update
title_full The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update
title_fullStr The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update
title_full_unstemmed The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update
title_sort The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update
author Araújo, Filipe C.
author_facet Araújo, Filipe C.
Sepriano, Alexandre
Teixeira, F.
Jesus, D.
Rocha, T. M.
Martins, Paula Andreia
Tenazinha, C.
Cordeiro, A.
Mourão, A. F.
Silva, C.
Vaz, C.
Duarte, C.
Ponte, C.
dos Santos, F. P.
Canhão, Helena
Santos, H.
Pimentão, J. B.
da Silva, J. C.
Polido-Pereira, J.
Miranda, L. C.
Oliveira, M.
Saavedra, M. J.
Gonçalves, P.
Falcão, S.
Capela, S.
Fonseca, J. E.
author_role author
author2 Sepriano, Alexandre
Teixeira, F.
Jesus, D.
Rocha, T. M.
Martins, Paula Andreia
Tenazinha, C.
Cordeiro, A.
Mourão, A. F.
Silva, C.
Vaz, C.
Duarte, C.
Ponte, C.
dos Santos, F. P.
Canhão, Helena
Santos, H.
Pimentão, J. B.
da Silva, J. C.
Polido-Pereira, J.
Miranda, L. C.
Oliveira, M.
Saavedra, M. J.
Gonçalves, P.
Falcão, S.
Capela, S.
Fonseca, J. E.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
Centro de Estudos de Doenças Crónicas (CEDOC)
RUN
dc.contributor.author.fl_str_mv Araújo, Filipe C.
Sepriano, Alexandre
Teixeira, F.
Jesus, D.
Rocha, T. M.
Martins, Paula Andreia
Tenazinha, C.
Cordeiro, A.
Mourão, A. F.
Silva, C.
Vaz, C.
Duarte, C.
Ponte, C.
dos Santos, F. P.
Canhão, Helena
Santos, H.
Pimentão, J. B.
da Silva, J. C.
Polido-Pereira, J.
da Silva, J. C.
Miranda, L. C.
Oliveira, M.
Saavedra, M. J.
Gonçalves, P.
Falcão, S.
Capela, S.
Fonseca, J. E.
dc.subject.por.fl_str_mv Ankylosing spondylitis
Anti-tumor necrosis factor-alpha therapy
Biosimilar
Rheumatoid arthritis
Rheumatology
topic Ankylosing spondylitis
Anti-tumor necrosis factor-alpha therapy
Biosimilar
Rheumatoid arthritis
Rheumatology
description Biosimilars are new and more affordable similar versions of previously approved reference biological drugs. Following the approval of the first monoclonal antibody biosimilar in 2013, the Portuguese Society of Rheumatology issued a position paper on the use of biosimilars in rheumatic conditions covering efficacy, safety, extrapolation, interchangeability, substitution and pharmacovigilance. However, as this is a rapidly evolving field, it was felt that the knowledge and evidence gathered since then justified an update of these statements. Literature searches on these issues were performed and the search results were presented and discussed in a national meeting. Portuguese rheumatologists considered that affordability should be taken into consideration when initiating a biological drug, but other factors were equally important. In patients already on reference biological treatment, switch to a more affordable biosimilar is desirable, provided a set of conditions is rigorously met. Automatic substitution is not acceptable and current evidence is insufficient to support interchangeability. Extrapolation of clinical indications is endorsed by Portuguese rheumatologists, and the statements on safety, pharmacovigilance and traceability are in accordance with the previous position paper.
publishDate 2018
dc.date.none.fl_str_mv 2018-03-15T23:18:48Z
2018-02
2018-02-01T00:00:00Z
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