Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison
- Autores
- Machado, Fernanda Lacerda da Silva; Cañás, Martín; Doubova, Svetlana V.; Urtasun, Martín Alejandro; Marin, Gustavo Horacio; Osorio de Castro, Claudia Garcia Serpa; Albuquerque, Flavia Caixeta; Ribeiro, Tatiane Bonfim; Pont, Lisa; Crisóstomo Landeros, José; Roldán Saelzer, Juan; Sepúlveda Viveros, Dino; Acosta, Angela; Machado Beltrán, Manuel A.; Gordillo Alas, Lily Iracema; 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; Lopes, Luciane Cruz
- 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.
Fil: Machado, Fernanda Lacerda da Silva. Universidade Federal do Rio de Janeiro; Brasil
Fil: Cañás, Martín. Universidad Nacional Arturo Jauretche; Argentina
Fil: Doubova, Svetlana V.. Mexican Institute Of Social Security; México
Fil: Urtasun, Martín Alejandro. Universidad Nacional Arturo Jauretche; Argentina
Fil: Marin, Gustavo Horacio. Universidad Nacional de La Plata; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Osorio de Castro, Claudia Garcia Serpa. Instituto Oswaldo Cruz; Brasil
Fil: Albuquerque, Flavia Caixeta. Sorocaba University; Brasil
Fil: Ribeiro, Tatiane Bonfim. Universidade de Sao Paulo; Brasil
Fil: Pont, Lisa. University of Technology Sydney; Australia
Fil: Crisóstomo Landeros, José. Instituto de Salud Pública de Chile; Chile
Fil: Roldán Saelzer, Juan. Instituto de Salud Pública de Chile; Chile
Fil: Sepúlveda Viveros, Dino. Universidad del Desarrollo; Chile. Universidad Autónoma de Chile; Chile
Fil: Acosta, Angela. Universidad Icesi; Colombia
Fil: Machado Beltrán, Manuel A.. Universidad Nacional de Colombia; Colombia
Fil: Gordillo Alas, Lily Iracema. Ministry of Public Health and Social Assistance; Guatemala
Fil: Orellana Tablas, Lourdes Abigail. Ministry of Public Health and Social Assistance; Guatemala
Fil: Benko, Ria. University of Szeged; Hungría
Fil: Convertino, Irma. University of Pisa; Italia
Fil: Bonaso, Marco. University of Pisa; Italia
Fil: Tuccori, Marco. University of Pisa; Italia
Fil: Kirchmayer, Ursula. Lazio Regional Health Service; Italia
Fil: Contreras Sánchez, Saúl E.. Mexican Institute of Social Security; México
Fil: Rodríguez Tanta, L. Yesenia. Universidad Cientifica del Sur;
Fil: Gutierrez Aures, Ysabel. Ministry of Health of Peru; Perú
Fil: Lin, Boya. University of Florida; Estados Unidos
Fil: Alipour Haris, Golnoosh. University of Florida; Estados Unidos
Fil: Eworuke, Efe. Real World Solutions; Estados Unidos
Fil: Lopes, Luciane Cruz. Sorocaba University; Brasil - Materia
-
BIOLOGICAL PRODUCTS
BIOSIMILARS
DRUG APPROVAL - Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
- Repositorio
.jpg)
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/223295
Ver los metadatos del registro completo
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Biosimilars approvals by thirteen regulatory authorities: A cross-national comparisonMachado, Fernanda Lacerda da SilvaCañás, MartínDoubova, Svetlana V.Urtasun, Martín AlejandroMarin, Gustavo HoracioOsorio de Castro, Claudia Garcia SerpaAlbuquerque, Flavia CaixetaRibeiro, Tatiane BonfimPont, LisaCrisóstomo Landeros, JoséRoldán Saelzer, JuanSepúlveda Viveros, DinoAcosta, AngelaMachado Beltrán, Manuel A.Gordillo Alas, Lily IracemaOrellana Tablas, Lourdes AbigailBenko, RiaConvertino, IrmaBonaso, MarcoTuccori, MarcoKirchmayer, UrsulaContreras Sánchez, Saúl E.Rodríguez Tanta, L. YeseniaGutierrez Aures, YsabelLin, BoyaAlipour Haris, GolnooshEworuke, EfeLopes, Luciane CruzBIOLOGICAL PRODUCTSBIOSIMILARSDRUG APPROVALhttps://purl.org/becyt/ford/3.1https://purl.org/becyt/ford/3Biosimilars 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.Fil: Machado, Fernanda Lacerda da Silva. Universidade Federal do Rio de Janeiro; BrasilFil: Cañás, Martín. Universidad Nacional Arturo Jauretche; ArgentinaFil: Doubova, Svetlana V.. Mexican Institute Of Social Security; MéxicoFil: Urtasun, Martín Alejandro. Universidad Nacional Arturo Jauretche; ArgentinaFil: Marin, Gustavo Horacio. Universidad Nacional de La Plata; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Osorio de Castro, Claudia Garcia Serpa. Instituto Oswaldo Cruz; BrasilFil: Albuquerque, Flavia Caixeta. Sorocaba University; BrasilFil: Ribeiro, Tatiane Bonfim. Universidade de Sao Paulo; BrasilFil: Pont, Lisa. University of Technology Sydney; AustraliaFil: Crisóstomo Landeros, José. Instituto de Salud Pública de Chile; ChileFil: Roldán Saelzer, Juan. Instituto de Salud Pública de Chile; ChileFil: Sepúlveda Viveros, Dino. Universidad del Desarrollo; Chile. Universidad Autónoma de Chile; ChileFil: Acosta, Angela. Universidad Icesi; ColombiaFil: Machado Beltrán, Manuel A.. Universidad Nacional de Colombia; ColombiaFil: Gordillo Alas, Lily Iracema. Ministry of Public Health and Social Assistance; GuatemalaFil: Orellana Tablas, Lourdes Abigail. Ministry of Public Health and Social Assistance; GuatemalaFil: Benko, Ria. University of Szeged; HungríaFil: Convertino, Irma. University of Pisa; ItaliaFil: Bonaso, Marco. University of Pisa; ItaliaFil: Tuccori, Marco. University of Pisa; ItaliaFil: Kirchmayer, Ursula. Lazio Regional Health Service; ItaliaFil: Contreras Sánchez, Saúl E.. Mexican Institute of Social Security; MéxicoFil: Rodríguez Tanta, L. Yesenia. Universidad Cientifica del Sur;Fil: Gutierrez Aures, Ysabel. Ministry of Health of Peru; PerúFil: Lin, Boya. University of Florida; Estados UnidosFil: Alipour Haris, Golnoosh. University of Florida; Estados UnidosFil: Eworuke, Efe. Real World Solutions; Estados UnidosFil: Lopes, Luciane Cruz. Sorocaba University; BrasilAcademic Press Inc Elsevier Science2023-09info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/223295Machado, Fernanda Lacerda da Silva; Cañás, Martín; Doubova, Svetlana V.; Urtasun, Martín Alejandro; Marin, Gustavo Horacio; et al.; Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison; Academic Press Inc Elsevier Science; Regulatory Toxicology And Pharmacology : Rtp.; 144; 1054; 9-2023; 1-90273-2300CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.yrtph.2023.105485info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S0273230023001538info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:44:10Zoai:ri.conicet.gov.ar:11336/223295instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:44:10.535CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse |
| dc.title.none.fl_str_mv |
Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison |
| title |
Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison |
| spellingShingle |
Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison Machado, Fernanda Lacerda da Silva BIOLOGICAL PRODUCTS BIOSIMILARS DRUG APPROVAL |
| title_short |
Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison |
| title_full |
Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison |
| title_fullStr |
Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison |
| title_full_unstemmed |
Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison |
| title_sort |
Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison |
| dc.creator.none.fl_str_mv |
Machado, Fernanda Lacerda da Silva Cañás, Martín Doubova, Svetlana V. Urtasun, Martín Alejandro Marin, Gustavo Horacio Osorio de Castro, Claudia Garcia Serpa Albuquerque, Flavia Caixeta Ribeiro, Tatiane Bonfim Pont, Lisa Crisóstomo Landeros, José Roldán Saelzer, Juan Sepúlveda Viveros, Dino Acosta, Angela Machado Beltrán, Manuel A. Gordillo Alas, Lily Iracema 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 Lopes, Luciane Cruz |
| author |
Machado, Fernanda Lacerda da Silva |
| author_facet |
Machado, Fernanda Lacerda da Silva Cañás, Martín Doubova, Svetlana V. Urtasun, Martín Alejandro Marin, Gustavo Horacio Osorio de Castro, Claudia Garcia Serpa Albuquerque, Flavia Caixeta Ribeiro, Tatiane Bonfim Pont, Lisa Crisóstomo Landeros, José Roldán Saelzer, Juan Sepúlveda Viveros, Dino Acosta, Angela Machado Beltrán, Manuel A. Gordillo Alas, Lily Iracema 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 Lopes, Luciane Cruz |
| author_role |
author |
| author2 |
Cañás, Martín Doubova, Svetlana V. Urtasun, Martín Alejandro Marin, Gustavo Horacio Osorio de Castro, Claudia Garcia Serpa Albuquerque, Flavia Caixeta Ribeiro, Tatiane Bonfim Pont, Lisa Crisóstomo Landeros, José Roldán Saelzer, Juan Sepúlveda Viveros, Dino Acosta, Angela Machado Beltrán, Manuel A. Gordillo Alas, Lily Iracema 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 Lopes, Luciane Cruz |
| 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 |
BIOLOGICAL PRODUCTS BIOSIMILARS DRUG APPROVAL |
| topic |
BIOLOGICAL PRODUCTS BIOSIMILARS DRUG APPROVAL |
| purl_subject.fl_str_mv |
https://purl.org/becyt/ford/3.1 https://purl.org/becyt/ford/3 |
| 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. Fil: Machado, Fernanda Lacerda da Silva. Universidade Federal do Rio de Janeiro; Brasil Fil: Cañás, Martín. Universidad Nacional Arturo Jauretche; Argentina Fil: Doubova, Svetlana V.. Mexican Institute Of Social Security; México Fil: Urtasun, Martín Alejandro. Universidad Nacional Arturo Jauretche; Argentina Fil: Marin, Gustavo Horacio. Universidad Nacional de La Plata; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina Fil: Osorio de Castro, Claudia Garcia Serpa. Instituto Oswaldo Cruz; Brasil Fil: Albuquerque, Flavia Caixeta. Sorocaba University; Brasil Fil: Ribeiro, Tatiane Bonfim. Universidade de Sao Paulo; Brasil Fil: Pont, Lisa. University of Technology Sydney; Australia Fil: Crisóstomo Landeros, José. Instituto de Salud Pública de Chile; Chile Fil: Roldán Saelzer, Juan. Instituto de Salud Pública de Chile; Chile Fil: Sepúlveda Viveros, Dino. Universidad del Desarrollo; Chile. Universidad Autónoma de Chile; Chile Fil: Acosta, Angela. Universidad Icesi; Colombia Fil: Machado Beltrán, Manuel A.. Universidad Nacional de Colombia; Colombia Fil: Gordillo Alas, Lily Iracema. Ministry of Public Health and Social Assistance; Guatemala Fil: Orellana Tablas, Lourdes Abigail. Ministry of Public Health and Social Assistance; Guatemala Fil: Benko, Ria. University of Szeged; Hungría Fil: Convertino, Irma. University of Pisa; Italia Fil: Bonaso, Marco. University of Pisa; Italia Fil: Tuccori, Marco. University of Pisa; Italia Fil: Kirchmayer, Ursula. Lazio Regional Health Service; Italia Fil: Contreras Sánchez, Saúl E.. Mexican Institute of Social Security; México Fil: Rodríguez Tanta, L. Yesenia. Universidad Cientifica del Sur; Fil: Gutierrez Aures, Ysabel. Ministry of Health of Peru; Perú Fil: Lin, Boya. University of Florida; Estados Unidos Fil: Alipour Haris, Golnoosh. University of Florida; Estados Unidos Fil: Eworuke, Efe. Real World Solutions; Estados Unidos Fil: Lopes, Luciane Cruz. Sorocaba University; Brasil |
| 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 |
2023-09 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://purl.org/coar/resource_type/c_6501 info:ar-repo/semantics/articulo |
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article |
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publishedVersion |
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http://hdl.handle.net/11336/223295 Machado, Fernanda Lacerda da Silva; Cañás, Martín; Doubova, Svetlana V.; Urtasun, Martín Alejandro; Marin, Gustavo Horacio; et al.; Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison; Academic Press Inc Elsevier Science; Regulatory Toxicology And Pharmacology : Rtp.; 144; 1054; 9-2023; 1-9 0273-2300 CONICET Digital CONICET |
| url |
http://hdl.handle.net/11336/223295 |
| identifier_str_mv |
Machado, Fernanda Lacerda da Silva; Cañás, Martín; Doubova, Svetlana V.; Urtasun, Martín Alejandro; Marin, Gustavo Horacio; et al.; Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison; Academic Press Inc Elsevier Science; Regulatory Toxicology And Pharmacology : Rtp.; 144; 1054; 9-2023; 1-9 0273-2300 CONICET Digital CONICET |
| dc.language.none.fl_str_mv |
eng |
| language |
eng |
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info:eu-repo/semantics/altIdentifier/doi/10.1016/j.yrtph.2023.105485 info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S0273230023001538 |
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info:eu-repo/semantics/openAccess https://creativecommons.org/licenses/by-nc-sa/2.5/ar/ |
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application/pdf application/pdf |
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Academic Press Inc Elsevier Science |
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Academic Press Inc Elsevier Science |
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dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar |
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