An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparison
- Autores
- Lacerda da Silva Machado, Fernanda; Cañás, Martín; Doubova, Svetlana V.; Urtasun, Martín Alejandro; Marín, Gustavo Horacio; Garcia Serpa Osorio-de-Castro, Claudia; Caixeta Albuquerque, Flavia; Bonfim Ribeiro, Tatiane; Pont, Lisa; Landeros, José Crisóstomo; Roldán Saelzer, Juan; Sepúlveda Viveros, Dino; Acosta, Angela; Machado Beltrán, Manuel A.; Iracema Gordillo Alas, Lily; Orellana Tablas, Lourdes Abigail; Benko, Ria; Convertino, Irma; Bonaso, Marco; Tuccori, Marco; Kirchmayer, Ursula; Contreras Sánchez, Saúl E.; Rodríguez Tanta, L. Yesenia; Gutierrez Aures, Ysabel; Lin, Boya; Alipour-Haris, Golnoosh; Eworuke, Efe; Cruz Lopes, Luciane
- Año de publicación
- 2023
- Idioma
- inglés
- Tipo de recurso
- artículo
- Estado
- versión publicada
- Descripción
- Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice.
Facultad de Ciencias Médicas - Materia
-
Medicina
biological products
biosimilars
drug approval - Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- http://creativecommons.org/licenses/by/4.0/
- Repositorio
- Institución
- Universidad Nacional de La Plata
- OAI Identificador
- oai:sedici.unlp.edu.ar:10915/159655
Ver los metadatos del registro completo
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An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparisonLacerda da Silva Machado, FernandaCañás, MartínDoubova, Svetlana V.Urtasun, Martín AlejandroMarín, Gustavo HoracioGarcia Serpa Osorio-de-Castro, ClaudiaCaixeta Albuquerque, FlaviaBonfim Ribeiro, TatianePont, LisaLanderos, José CrisóstomoRoldán Saelzer, JuanSepúlveda Viveros, DinoAcosta, AngelaMachado Beltrán, Manuel A.Iracema Gordillo Alas, LilyOrellana Tablas, Lourdes AbigailBenko, RiaConvertino, IrmaBonaso, MarcoTuccori, MarcoKirchmayer, UrsulaContreras Sánchez, Saúl E.Rodríguez Tanta, L. YeseniaGutierrez Aures, YsabelLin, BoyaAlipour-Haris, GolnooshEworuke, EfeCruz Lopes, LucianeMedicinabiological productsbiosimilarsdrug approvalBiosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice.Facultad de Ciencias Médicas2023-10info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionArticulohttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfhttp://sedici.unlp.edu.ar/handle/10915/159655enginfo:eu-repo/semantics/altIdentifier/issn/0273-2300info:eu-repo/semantics/altIdentifier/doi/10.1016/j.yrtph.2023.105485info:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by/4.0/Creative Commons Attribution 4.0 International (CC BY 4.0)reponame:SEDICI (UNLP)instname:Universidad Nacional de La Platainstacron:UNLP2025-09-29T11:41:41Zoai:sedici.unlp.edu.ar:10915/159655Institucionalhttp://sedici.unlp.edu.ar/Universidad públicaNo correspondehttp://sedici.unlp.edu.ar/oai/snrdalira@sedici.unlp.edu.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:13292025-09-29 11:41:41.677SEDICI (UNLP) - Universidad Nacional de La Platafalse |
dc.title.none.fl_str_mv |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparison |
title |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparison |
spellingShingle |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparison Lacerda da Silva Machado, Fernanda Medicina biological products biosimilars drug approval |
title_short |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparison |
title_full |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparison |
title_fullStr |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparison |
title_full_unstemmed |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparison |
title_sort |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparison |
dc.creator.none.fl_str_mv |
Lacerda da Silva Machado, Fernanda Cañás, Martín Doubova, Svetlana V. Urtasun, Martín Alejandro Marín, Gustavo Horacio Garcia Serpa Osorio-de-Castro, Claudia Caixeta Albuquerque, Flavia Bonfim Ribeiro, Tatiane Pont, Lisa Landeros, José Crisóstomo Roldán Saelzer, Juan Sepúlveda Viveros, Dino Acosta, Angela Machado Beltrán, Manuel A. Iracema Gordillo Alas, Lily Orellana Tablas, Lourdes Abigail Benko, Ria Convertino, Irma Bonaso, Marco Tuccori, Marco Kirchmayer, Ursula Contreras Sánchez, Saúl E. Rodríguez Tanta, L. Yesenia Gutierrez Aures, Ysabel Lin, Boya Alipour-Haris, Golnoosh Eworuke, Efe Cruz Lopes, Luciane |
author |
Lacerda da Silva Machado, Fernanda |
author_facet |
Lacerda da Silva Machado, Fernanda Cañás, Martín Doubova, Svetlana V. Urtasun, Martín Alejandro Marín, Gustavo Horacio Garcia Serpa Osorio-de-Castro, Claudia Caixeta Albuquerque, Flavia Bonfim Ribeiro, Tatiane Pont, Lisa Landeros, José Crisóstomo Roldán Saelzer, Juan Sepúlveda Viveros, Dino Acosta, Angela Machado Beltrán, Manuel A. Iracema Gordillo Alas, Lily Orellana Tablas, Lourdes Abigail Benko, Ria Convertino, Irma Bonaso, Marco Tuccori, Marco Kirchmayer, Ursula Contreras Sánchez, Saúl E. Rodríguez Tanta, L. Yesenia Gutierrez Aures, Ysabel Lin, Boya Alipour-Haris, Golnoosh Eworuke, Efe Cruz Lopes, Luciane |
author_role |
author |
author2 |
Cañás, Martín Doubova, Svetlana V. Urtasun, Martín Alejandro Marín, Gustavo Horacio Garcia Serpa Osorio-de-Castro, Claudia Caixeta Albuquerque, Flavia Bonfim Ribeiro, Tatiane Pont, Lisa Landeros, José Crisóstomo Roldán Saelzer, Juan Sepúlveda Viveros, Dino Acosta, Angela Machado Beltrán, Manuel A. Iracema Gordillo Alas, Lily Orellana Tablas, Lourdes Abigail Benko, Ria Convertino, Irma Bonaso, Marco Tuccori, Marco Kirchmayer, Ursula Contreras Sánchez, Saúl E. Rodríguez Tanta, L. Yesenia Gutierrez Aures, Ysabel Lin, Boya Alipour-Haris, Golnoosh Eworuke, Efe Cruz Lopes, Luciane |
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 author author |
dc.subject.none.fl_str_mv |
Medicina biological products biosimilars drug approval |
topic |
Medicina biological products biosimilars drug approval |
dc.description.none.fl_txt_mv |
Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice. Facultad de Ciencias Médicas |
description |
Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice. |
publishDate |
2023 |
dc.date.none.fl_str_mv |
2023-10 |
dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Articulo http://purl.org/coar/resource_type/c_6501 info:ar-repo/semantics/articulo |
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openAccess |
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http://creativecommons.org/licenses/by/4.0/ Creative Commons Attribution 4.0 International (CC BY 4.0) |
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