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

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-natio...

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Published in:	Regulatory toxicology and pharmacology Vol. 144; p. 105485
Main Authors:	Machado, Fernanda Lacerda da Silva, Cañás, Martín, Doubova, Svetlana V., Urtasun, Martín A., Marín, Gustavo H., 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
Format:	Journal Article
Language:	English
Published:	Elsevier Inc 01-10-2023
Subjects:	Biological products Biosimilars Drug approval Biosimilars Drug approval Biological products
Online Access:	Get full text
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Summary:	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. •All the regulatory authorities published guidelines for licensing of biosimilars with definitions aligned with the World Health Organization.•The number of biosimilars approved has risen in the last years, yet there was a marked variation in timing and quantity in different jurisdictions.•Most of the regulatory authorities should strength access to information regarding the assessment of biosimilars.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0273-2300 1096-0295
DOI:	10.1016/j.yrtph.2023.105485