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dc.contributor.author
Machado, Fernanda Lacerda da Silva
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Cañás, Martín
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Doubova, Svetlana V.
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Urtasun, Martín Alejandro
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Marin, Gustavo Horacio
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Osorio de Castro, Claudia Garcia Serpa
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Albuquerque, Flavia Caixeta
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Ribeiro, Tatiane Bonfim
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Pont, Lisa
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Crisóstomo Landeros, José
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Roldán Saelzer, Juan
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Sepúlveda Viveros, Dino
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Acosta, Angela
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Machado Beltrán, Manuel A.
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Gordillo Alas, Lily Iracema
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Orellana Tablas, Lourdes Abigail
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Benko, Ria
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Convertino, Irma
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Bonaso, Marco
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Tuccori, Marco
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Kirchmayer, Ursula
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Contreras Sánchez, Saúl E.
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Rodríguez Tanta, L. Yesenia
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Gutierrez Aures, Ysabel
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Lin, Boya
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Alipour Haris, Golnoosh
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Eworuke, Efe
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Lopes, Luciane Cruz
dc.date.available
2024-01-11T11:34:53Z
dc.date.issued
2023-09
dc.identifier.citation
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
dc.identifier.issn
0273-2300
dc.identifier.uri
http://hdl.handle.net/11336/223295
dc.description.abstract
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.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Academic Press Inc Elsevier Science
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dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject
BIOLOGICAL PRODUCTS
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BIOSIMILARS
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DRUG APPROVAL
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Farmacología y Farmacia
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Medicina Básica
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CIENCIAS MÉDICAS Y DE LA SALUD
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dc.title
Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison
dc.type
info:eu-repo/semantics/article
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info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2024-01-10T13:51:32Z
dc.journal.volume
144
dc.journal.number
1054
dc.journal.pagination
1-9
dc.journal.pais
Estados Unidos
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dc.journal.ciudad
Amsterdam
dc.description.fil
Fil: Machado, Fernanda Lacerda da Silva. Universidade Federal do Rio de Janeiro; Brasil
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Fil: Cañás, Martín. Universidad Nacional Arturo Jauretche; Argentina
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Fil: Doubova, Svetlana V.. Mexican Institute Of Social Security; México
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Fil: Urtasun, Martín Alejandro. Universidad Nacional Arturo Jauretche; Argentina
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Fil: Marin, Gustavo Horacio. Universidad Nacional de La Plata; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
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Fil: Osorio de Castro, Claudia Garcia Serpa. Instituto Oswaldo Cruz; Brasil
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Fil: Albuquerque, Flavia Caixeta. Sorocaba University; Brasil
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Fil: Ribeiro, Tatiane Bonfim. Universidade de Sao Paulo; Brasil
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Fil: Pont, Lisa. University of Technology Sydney; Australia
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Fil: Crisóstomo Landeros, José. Instituto de Salud Pública de Chile; Chile
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Fil: Roldán Saelzer, Juan. Instituto de Salud Pública de Chile; Chile
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Fil: Sepúlveda Viveros, Dino. Universidad del Desarrollo; Chile. Universidad Autónoma de Chile; Chile
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Fil: Acosta, Angela. Universidad Icesi; Colombia
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Fil: Machado Beltrán, Manuel A.. Universidad Nacional de Colombia; Colombia
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Fil: Gordillo Alas, Lily Iracema. Ministry of Public Health and Social Assistance; Guatemala
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Fil: Orellana Tablas, Lourdes Abigail. Ministry of Public Health and Social Assistance; Guatemala
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Fil: Benko, Ria. University of Szeged; Hungría
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Fil: Convertino, Irma. University of Pisa; Italia
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Fil: Bonaso, Marco. University of Pisa; Italia
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Fil: Tuccori, Marco. University of Pisa; Italia
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Fil: Kirchmayer, Ursula. Lazio Regional Health Service; Italia
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Fil: Contreras Sánchez, Saúl E.. Mexican Institute of Social Security; México
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Fil: Rodríguez Tanta, L. Yesenia. Universidad Cientifica del Sur;
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Fil: Gutierrez Aures, Ysabel. Ministry of Health of Peru; Perú
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Fil: Lin, Boya. University of Florida; Estados Unidos
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Fil: Alipour Haris, Golnoosh. University of Florida; Estados Unidos
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Fil: Eworuke, Efe. Real World Solutions; Estados Unidos
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Fil: Lopes, Luciane Cruz. Sorocaba University; Brasil
dc.journal.title
Regulatory Toxicology And Pharmacology : Rtp.
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dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1016/j.yrtph.2023.105485
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info:eu-repo/semantics/altIdentifier/url/https://www.sciencedirect.com/science/article/pii/S0273230023001538
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