Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review

Detalhes bibliográficos
Autor(a) principal: Machado, Sara 
Data de Publicação: 2024
Outros Autores: Cruz, Agostinho, Ferreira, Pedro Lopes , Morais, Carminda , Pimenta, Rui
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10400.22/25399
Resumo: While biosimilar medicines can contribute to the sustainability of healthcare systems, their utilization rate varies across European countries. This study aims to identify and systematize policy measures and instruments used in European countries to increase biosimilar market share. A systematic review was conducted according to PRISMA 2020 recommendations. Medline-PubMed, Web of Science and ScienceDirect databases were searched using inclusion criteria that required full articles published in English between January 2006 and November 2023. Reviews, letters, reports, editorials and comments or opinion articles were excluded from this study. Of the 1,137 articles, only 13 met the eligibility criteria for analysis, which covered a total of 28 European countries. Pricing regulation measures were found in 27 of these countries with tendering, price-linkage and internal reference price being the most used. Tendering was used by 27 countries to procure biosimilars in inpatient setting. Prescribing guidelines and recommendations were the widely used instrument. Some European countries adopted physician incentives, quotas, and prescription by international non-proprietary name. Automatic substitution was not commonly recommended or applied. Interchangeability and switching will become increasingly relevant issues. It is important that the positive results from some countries serve as an example for the future of these medicines in the European market.
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spelling Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic reviewBiological productsBiosimilar pharmaceuticalsDrug substitutionHealth policyEconomicsWhile biosimilar medicines can contribute to the sustainability of healthcare systems, their utilization rate varies across European countries. This study aims to identify and systematize policy measures and instruments used in European countries to increase biosimilar market share. A systematic review was conducted according to PRISMA 2020 recommendations. Medline-PubMed, Web of Science and ScienceDirect databases were searched using inclusion criteria that required full articles published in English between January 2006 and November 2023. Reviews, letters, reports, editorials and comments or opinion articles were excluded from this study. Of the 1,137 articles, only 13 met the eligibility criteria for analysis, which covered a total of 28 European countries. Pricing regulation measures were found in 27 of these countries with tendering, price-linkage and internal reference price being the most used. Tendering was used by 27 countries to procure biosimilars in inpatient setting. Prescribing guidelines and recommendations were the widely used instrument. Some European countries adopted physician incentives, quotas, and prescription by international non-proprietary name. Automatic substitution was not commonly recommended or applied. Interchangeability and switching will become increasingly relevant issues. It is important that the positive results from some countries serve as an example for the future of these medicines in the European market.FrontiersRepositório Científico do Instituto Politécnico do PortoMachado, Sara Cruz, AgostinhoFerreira, Pedro Lopes Morais, Carminda Pimenta, Rui2024-04-23T15:23:25Z2024-02-282024-02-28T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.22/25399engMachado, S., Cruz, A., Ferreira, P. L., Morais, C., & Pimenta, R. E. (2024). Policy measures and instruments used in European countries to increase biosimilar uptake: A systematic review. Frontiers in Public Health, 12, 1–9. https://doi.org/10.3389/fpubh.2024.12634722296-256510.3389/fpubh.2024.1263472info: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:RCAAP2024-05-01T01:46:09Zoai:recipp.ipp.pt:10400.22/25399Portal AgregadorONGhttps://www.rcaap.pt/oai/openairemluisa.alvim@gmail.comopendoar:71602024-05-01T01:46:09Repositório 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 Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review
title Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review
spellingShingle Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review
Machado, Sara 
Biological products
Biosimilar pharmaceuticals
Drug substitution
Health policy
Economics
title_short Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review
title_full Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review
title_fullStr Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review
title_full_unstemmed Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review
title_sort Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review
author Machado, Sara 
author_facet Machado, Sara 
Cruz, Agostinho
Ferreira, Pedro Lopes 
Morais, Carminda 
Pimenta, Rui
author_role author
author2 Cruz, Agostinho
Ferreira, Pedro Lopes 
Morais, Carminda 
Pimenta, Rui
author2_role author
author
author
author
dc.contributor.none.fl_str_mv Repositório Científico do Instituto Politécnico do Porto
dc.contributor.author.fl_str_mv Machado, Sara 
Cruz, Agostinho
Ferreira, Pedro Lopes 
Morais, Carminda 
Pimenta, Rui
dc.subject.por.fl_str_mv Biological products
Biosimilar pharmaceuticals
Drug substitution
Health policy
Economics
topic Biological products
Biosimilar pharmaceuticals
Drug substitution
Health policy
Economics
description While biosimilar medicines can contribute to the sustainability of healthcare systems, their utilization rate varies across European countries. This study aims to identify and systematize policy measures and instruments used in European countries to increase biosimilar market share. A systematic review was conducted according to PRISMA 2020 recommendations. Medline-PubMed, Web of Science and ScienceDirect databases were searched using inclusion criteria that required full articles published in English between January 2006 and November 2023. Reviews, letters, reports, editorials and comments or opinion articles were excluded from this study. Of the 1,137 articles, only 13 met the eligibility criteria for analysis, which covered a total of 28 European countries. Pricing regulation measures were found in 27 of these countries with tendering, price-linkage and internal reference price being the most used. Tendering was used by 27 countries to procure biosimilars in inpatient setting. Prescribing guidelines and recommendations were the widely used instrument. Some European countries adopted physician incentives, quotas, and prescription by international non-proprietary name. Automatic substitution was not commonly recommended or applied. Interchangeability and switching will become increasingly relevant issues. It is important that the positive results from some countries serve as an example for the future of these medicines in the European market.
publishDate 2024
dc.date.none.fl_str_mv 2024-04-23T15:23:25Z
2024-02-28
2024-02-28T00:00:00Z
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://hdl.handle.net/10400.22/25399
url http://hdl.handle.net/10400.22/25399
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Machado, S., Cruz, A., Ferreira, P. L., Morais, C., & Pimenta, R. E. (2024). Policy measures and instruments used in European countries to increase biosimilar uptake: A systematic review. Frontiers in Public Health, 12, 1–9. https://doi.org/10.3389/fpubh.2024.1263472
2296-2565
10.3389/fpubh.2024.1263472
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Frontiers
publisher.none.fl_str_mv Frontiers
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 mluisa.alvim@gmail.com
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