The Portuguese Society of Rheumatology position paper on the use of biosimilars - 2017 update
Autor(a) principal: | |
---|---|
Data de Publicação: | 2018 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , |
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. |
id |
RCAP_3cc0473e6b8463eaea989c0a9fe9820b |
---|---|
oai_identifier_str |
oai:run.unl.pt:10362/32618 |
network_acronym_str |
RCAP |
network_name_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository_id_str |
7160 |
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 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://www.scopus.com/inward/record.url?scp=85042565771&partnerID=8YFLogxK |
url |
http://www.scopus.com/inward/record.url?scp=85042565771&partnerID=8YFLogxK |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
0303-464X PURE: 3693959 http://www.scopus.com/inward/record.url?scp=85042565771&partnerID=8YFLogxK |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
10 application/pdf |
dc.source.none.fl_str_mv |
reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
instname_str |
Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
instacron_str |
RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
collection |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository.name.fl_str_mv |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
repository.mail.fl_str_mv |
|
_version_ |
1799137923934715904 |