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

Fernanda Lacerda da Silva Machado; Martín Cañás; Svetlana V. Doubova; Martín A. Urtasun; Gustavo H. Marín; Claudia Garcia Serpa Osorio-de-Castro; Flavia Caixeta Albuquerque; Tatiane Bonfim Ribeiro; Lisa Pont; José Crisóstomo Landeros; Juan Roldán Saelzer; Dino Sepúlveda Viveros; Angela Acosta; Manuel A. Machado Beltrán; Lily Iracema Gordillo Alas; Lourdes Abigail Orellana Tablas; Ria Benko; Irma Convertino; Marco Bonaso; Marco Tuccori; Ursula Kirchmayer; Saúl E. Contreras Sánchez; L. Yesenia Rodríguez-Tanta; Ysabel Gutierrez Aures; Boya Lin; Golnoosh Alipour-Haris; Efe Eworuke; Luciane Cruz Lopes

doi:10.1016/j.yrtph.2023.105485

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

Fernanda Lacerda da Silva Machado, Martín Cañás, Svetlana V. Doubova, Martín A. Urtasun, Gustavo H. Marín, Claudia Garcia Serpa Osorio-de-Castro, Flavia Caixeta Albuquerque, Tatiane Bonfim Ribeiro, Lisa Pont, José Crisóstomo Landeros, Juan Roldán Saelzer, Dino Sepúlveda Viveros, Angela Acosta, Manuel A. Machado Beltrán, Lily Iracema Gordillo Alas, Lourdes Abigail Orellana Tablas, Ria Benko, Irma Convertino, Marco Bonaso, Marco TuccoriUrsula Kirchmayer, Saúl E. Contreras Sánchez, L. Yesenia Rodríguez-Tanta, Ysabel Gutierrez Aures, Boya Lin, Golnoosh Alipour-Haris, Efe Eworuke, Luciane Cruz Lopes

Universidad Científica del Sur

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

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.

Original language	English
Article number	105485
Journal	Regulatory Toxicology and Pharmacology
Volume	144
DOIs	https://doi.org/10.1016/j.yrtph.2023.105485
State	Published - Oct 2023

Keywords

Biological products
Biosimilars
Drug approval

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10.1016/j.yrtph.2023.105485

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Machado, F. L. D. S., Cañás, M., Doubova, S. V., Urtasun, M. A., Marín, G. H., Osorio-de-Castro, C. G. S., Albuquerque, F. C., Ribeiro, T. B., Pont, L., Crisóstomo Landeros, J., Roldán Saelzer, J., Sepúlveda Viveros, D., Acosta, A., Machado Beltrán, M. A., Gordillo Alas, L. I., Orellana Tablas, L. A., Benko, R., Convertino, I., Bonaso, M., ... Lopes, L. C. (2023). Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison. Regulatory Toxicology and Pharmacology, 144, Article 105485. https://doi.org/10.1016/j.yrtph.2023.105485

@article{e4d9fcf81782448992eb1d42cbb57de6,

title = "Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison",

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.",

keywords = "Biological products, Biosimilars, Drug approval",

author = "Machado, {Fernanda Lacerda da Silva} and Mart{\'i}n Ca{\~n}{\'a}s and Doubova, {Svetlana V.} and Urtasun, {Mart{\'i}n A.} and Mar{\'i}n, {Gustavo H.} and Osorio-de-Castro, {Claudia Garcia Serpa} and Albuquerque, {Flavia Caixeta} and Ribeiro, {Tatiane Bonfim} and Lisa Pont and {Cris{\'o}stomo Landeros}, Jos{\'e} and {Rold{\'a}n Saelzer}, Juan and {Sep{\'u}lveda Viveros}, Dino and Angela Acosta and {Machado Beltr{\'a}n}, {Manuel A.} and {Gordillo Alas}, {Lily Iracema} and {Orellana Tablas}, {Lourdes Abigail} and Ria Benko and Irma Convertino and Marco Bonaso and Marco Tuccori and Ursula Kirchmayer and {Contreras S{\'a}nchez}, {Sa{\'u}l E.} and Rodr{\'i}guez-Tanta, {L. Yesenia} and {Gutierrez Aures}, Ysabel and Boya Lin and Golnoosh Alipour-Haris and Efe Eworuke and Lopes, {Luciane Cruz}",

note = "Publisher Copyright: {\textcopyright} 2023 Elsevier Inc.",

year = "2023",

month = oct,

doi = "10.1016/j.yrtph.2023.105485",

language = "Ingl{\'e}s",

volume = "144",

journal = "Regulatory Toxicology and Pharmacology",

issn = "0273-2300",

publisher = "Academic Press Inc.",

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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 2023, 'Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison', Regulatory Toxicology and Pharmacology, vol. 144, 105485. https://doi.org/10.1016/j.yrtph.2023.105485

TY - JOUR

T1 - Biosimilars approvals by thirteen regulatory authorities

T2 - A cross-national comparison

AU - Machado, Fernanda Lacerda da Silva

AU - Cañás, Martín

AU - Doubova, Svetlana V.

AU - Urtasun, Martín A.

AU - Marín, Gustavo H.

AU - Osorio-de-Castro, Claudia Garcia Serpa

AU - Albuquerque, Flavia Caixeta

AU - Ribeiro, Tatiane Bonfim

AU - Pont, Lisa

AU - Crisóstomo Landeros, José

AU - Roldán Saelzer, Juan

AU - Sepúlveda Viveros, Dino

AU - Acosta, Angela

AU - Machado Beltrán, Manuel A.

AU - Gordillo Alas, Lily Iracema

AU - Orellana Tablas, Lourdes Abigail

AU - Benko, Ria

AU - Convertino, Irma

AU - Bonaso, Marco

AU - Tuccori, Marco

AU - Kirchmayer, Ursula

AU - Contreras Sánchez, Saúl E.

AU - Rodríguez-Tanta, L. Yesenia

AU - Gutierrez Aures, Ysabel

AU - Lin, Boya

AU - Alipour-Haris, Golnoosh

AU - Eworuke, Efe

AU - Lopes, Luciane Cruz

PY - 2023/10

Y1 - 2023/10

N2 - 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.

AB - 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.

KW - Biological products

KW - Biosimilars

KW - Drug approval

UR - http://www.scopus.com/inward/record.url?scp=85170417399&partnerID=8YFLogxK

U2 - 10.1016/j.yrtph.2023.105485

DO - 10.1016/j.yrtph.2023.105485

M3 - Artículo

C2 - 37659711

AN - SCOPUS:85170417399

SN - 0273-2300

VL - 144

JO - Regulatory Toxicology and Pharmacology

JF - Regulatory Toxicology and Pharmacology

M1 - 105485

ER -

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

Abstract

Keywords

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