Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison.

Machado, FLDS; Cañás, M; Doubova, SV; Urtasun, MA; Marín, GH; Osorio-de-Castro, CGS; Albuquerque, FC; Ribeiro, TB; Pont, L; Crisóstomo Landeros, J; Roldán Saelzer, J; Sepúlveda Viveros, D; Acosta, A; Machado Beltrán, MA; Gordillo Alas, LI; Orellana Tablas, LA; Benko, R; Convertino, I; Bonaso, M; Tuccori, M; Kirchmayer, U; Contreras Sánchez, SE; Rodríguez-Tanta, LY; Gutierrez Aures, Y; Lin, B; Alipour-Haris, G; Eworuke, E; Lopes, LC

Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison.

Machado, FLDS Cañás, M Doubova, SV Urtasun, MA Marín, GH Osorio-de-Castro, CGS Albuquerque, FC Ribeiro, TB Pont, L

Crisóstomo Landeros, J Roldán Saelzer, J Sepúlveda Viveros, D Acosta, A Machado Beltrán, MA Gordillo Alas, LI Orellana Tablas, LA Benko, R Convertino, I Bonaso, M Tuccori, M Kirchmayer, U Contreras Sánchez, SE Rodríguez-Tanta, LY Gutierrez Aures, Y Lin, B Alipour-Haris, G Eworuke, E Lopes, LC

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Publisher:: Elsevier
Publication Type:: Journal Article
Citation:: Regul Toxicol Pharmacol, 2023, 144, pp. 105485
Issue Date:: 2023-09-01

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Field	Value	Language
dc.contributor.author	Machado, FLDS
dc.contributor.author	Cañás, M
dc.contributor.author	Doubova, SV
dc.contributor.author	Urtasun, MA
dc.contributor.author	Marín, GH
dc.contributor.author	Osorio-de-Castro, CGS
dc.contributor.author	Albuquerque, FC
dc.contributor.author	Ribeiro, TB
dc.contributor.author	Pont, L https://orcid.org/0000-0002-8545-716X
dc.contributor.author	Crisóstomo Landeros, J
dc.contributor.author	Roldán Saelzer, J
dc.contributor.author	Sepúlveda Viveros, D
dc.contributor.author	Acosta, A
dc.contributor.author	Machado Beltrán, MA
dc.contributor.author	Gordillo Alas, LI
dc.contributor.author	Orellana Tablas, LA
dc.contributor.author	Benko, R
dc.contributor.author	Convertino, I
dc.contributor.author	Bonaso, M
dc.contributor.author	Tuccori, M
dc.contributor.author	Kirchmayer, U
dc.contributor.author	Contreras Sánchez, SE
dc.contributor.author	Rodríguez-Tanta, LY
dc.contributor.author	Gutierrez Aures, Y
dc.contributor.author	Lin, B
dc.contributor.author	Alipour-Haris, G
dc.contributor.author	Eworuke, E
dc.contributor.author	Lopes, LC
dc.date.accessioned	2023-10-06T00:26:26Z
dc.date.available	2023-08-23
dc.date.available	2023-10-06T00:26:26Z
dc.date.issued	2023-09-01
dc.identifier.citation	Regul Toxicol Pharmacol, 2023, 144, pp. 105485
dc.identifier.issn	0273-2300
dc.identifier.issn	1096-0295
dc.identifier.uri	http://hdl.handle.net/10453/172526
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	Print-Electronic
dc.language	eng
dc.publisher	Elsevier
dc.relation.ispartof	Regul Toxicol Pharmacol
dc.relation.isbasedon	10.1016/j.yrtph.2023.105485
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject	1115 Pharmacology and Pharmaceutical Sciences
dc.subject.classification	Toxicology
dc.subject.classification	3214 Pharmacology and pharmaceutical sciences
dc.title	Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison.
dc.type	Journal Article
utslib.citation.volume	144
utslib.location.activity	Netherlands
utslib.for	1115 Pharmacology and Pharmaceutical Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
utslib.copyright.status	closed_access	*
dc.date.updated	2023-10-06T00:26:25Z
pubs.publication-status	Published online
pubs.volume	144

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.

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http://hdl.handle.net/10453/172526