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
SEDICI (UNLP)
Institución
Universidad Nacional de La Plata
OAI Identificador
oai:sedici.unlp.edu.ar:10915/159655

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spelling 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
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