An overview of 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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| Formato: | Articulo |
| Lenguaje: | Inglés |
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2023
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| Acceso en línea: | http://sedici.unlp.edu.ar/handle/10915/159655 |
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I19-R120-10915-159655 |
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I19-R120-10915-1596552023-10-31T20:08:20Z http://sedici.unlp.edu.ar/handle/10915/159655 An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparison Lacerda da Silva Machado, Fernanda Cañás, Martín Doubova, Svetlana V. Urtasun, Martín Alejandro Marín, Gustavo Horacio Garcia Serpa Osorio-de-Castro, Claudia Caixeta Albuquerque, Flavia Bonfim Ribeiro, Tatiane Pont, Lisa Landeros, José Crisóstomo Roldán Saelzer, Juan Sepúlveda Viveros, Dino Acosta, Angela Machado Beltrán, Manuel A. Iracema Gordillo Alas, Lily 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 Cruz Lopes, Luciane 2023-10 2023-10-31T19:04:58Z en Medicina biological products biosimilars drug approval 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. Facultad de Ciencias Médicas Articulo Articulo http://creativecommons.org/licenses/by/4.0/ Creative Commons Attribution 4.0 International (CC BY 4.0) application/pdf |
| institution |
Universidad Nacional de La Plata |
| institution_str |
I-19 |
| repository_str |
R-120 |
| collection |
SEDICI (UNLP) |
| language |
Inglés |
| topic |
Medicina biological products biosimilars drug approval |
| spellingShingle |
Medicina biological products biosimilars drug approval Lacerda da Silva Machado, Fernanda Cañás, Martín Doubova, Svetlana V. Urtasun, Martín Alejandro Marín, Gustavo Horacio Garcia Serpa Osorio-de-Castro, Claudia Caixeta Albuquerque, Flavia Bonfim Ribeiro, Tatiane Pont, Lisa Landeros, José Crisóstomo Roldán Saelzer, Juan Sepúlveda Viveros, Dino Acosta, Angela Machado Beltrán, Manuel A. Iracema Gordillo Alas, Lily 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 Cruz Lopes, Luciane An overview of biosimilars approvals by thirteen regulatory authorities: A cross national comparison |
| topic_facet |
Medicina biological products biosimilars drug approval |
| 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. |
| format |
Articulo Articulo |
| author |
Lacerda da Silva Machado, Fernanda Cañás, Martín Doubova, Svetlana V. Urtasun, Martín Alejandro Marín, Gustavo Horacio Garcia Serpa Osorio-de-Castro, Claudia Caixeta Albuquerque, Flavia Bonfim Ribeiro, Tatiane Pont, Lisa Landeros, José Crisóstomo Roldán Saelzer, Juan Sepúlveda Viveros, Dino Acosta, Angela Machado Beltrán, Manuel A. Iracema Gordillo Alas, Lily 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 Cruz Lopes, Luciane |
| author_facet |
Lacerda da Silva Machado, Fernanda Cañás, Martín Doubova, Svetlana V. Urtasun, Martín Alejandro Marín, Gustavo Horacio Garcia Serpa Osorio-de-Castro, Claudia Caixeta Albuquerque, Flavia Bonfim Ribeiro, Tatiane Pont, Lisa Landeros, José Crisóstomo Roldán Saelzer, Juan Sepúlveda Viveros, Dino Acosta, Angela Machado Beltrán, Manuel A. Iracema Gordillo Alas, Lily 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 Cruz Lopes, Luciane |
| author_sort |
Lacerda da Silva Machado, Fernanda |
| title |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national
comparison |
| title_short |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national
comparison |
| title_full |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national
comparison |
| title_fullStr |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national
comparison |
| title_full_unstemmed |
An overview of biosimilars approvals by thirteen regulatory authorities: A cross national
comparison |
| title_sort |
overview of biosimilars approvals by thirteen regulatory authorities: a cross national
comparison |
| publishDate |
2023 |
| url |
http://sedici.unlp.edu.ar/handle/10915/159655 |
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