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| DOI | 10.1016/J.YRTPH.2023.105485 | ||||
| Año | 2023 | ||||
| Tipo | artículo de investigación |
Citas Totales
Autores Afiliación Chile
Instituciones Chile
% Participación
Internacional
Autores
Afiliación Extranjera
Instituciones
Extranjeras
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.
| Ord. | Autor | Género | Institución - País |
|---|---|---|---|
| 1 | Machado, Fernanda Lacerda da Silva | - |
UNIV FED RIO DE JANEIRO - Brasil
Sorocaba Univ - Brasil Universidade Federal do Rio de Janeiro - Brasil Universidade de Sorocaba - Brasil |
| 2 | Canas, Martin | Hombre |
Univ Nacl Arturo Jauretche FEMEBA - Argentina
Universidad Nacional Arturo Jauretche - Argentina |
| 3 | Doubova, Svetlana V. | Mujer |
Mexican Inst Social Secur - México
Instituto Mexicano del Seguro Social - México |
| 4 | Urtasun, Martin A. | Hombre |
Univ Nacl Arturo Jauretche FEMEBA - Argentina
Universidad Nacional Arturo Jauretche - Argentina |
| 5 | Marin, Gustavo H. | - |
UNIV NACL LA PLATA - Argentina
Universidad Nacional de La Plata - Argentina |
| 6 | Osorio-de-Castro, Claudia Garcia Serpa | Mujer |
Fundacao Oswaldo Cruz - Brasil
|
| 7 | Albuquerque, Flavia Caixeta | - |
Minist Hlth - Brasil
Ministerio da Saude - Brasil |
| 8 | Ribeiro, Tatiane Bonfim | - |
UNIV SAO PAULO - Brasil
Universidade de São Paulo - Brasil |
| 9 | Pont, Lisa G. | Mujer |
Univ Technol Sydney - Australia
University of Technology Sydney - Australia |
| 10 | Crisóstomo Landeros, José | - |
Instituto de Salud Pública de Chile - Chile
Inst Salud Publ Chile - Chile |
| 10 | Landeros, Jose Crisostomo | - |
Inst Salud Publ Chile - Chile
Instituto de Salud Pública de Chile - Chile |
| 11 | Saelzer, Juan Roldan | - |
Inst Salud Publ Chile - Chile
Instituto de Salud Pública de Chile - Chile |
| 11 | Roldán Saelzer, Juan | - |
Instituto de Salud Pública de Chile - Chile
Inst Salud Publ Chile - Chile |
| 12 | Viveros, Dino Sepulveda | - |
Universidad Autónoma de Chile - Chile
Universidad del Desarrollo - Chile |
| 12 | VILLARROEL-VILLARROEL, LUIS | Hombre |
Universidad Autónoma de Chile - Chile
Universidad del Desarrollo - Chile |
| 13 | Acosta, Angela | Mujer |
Univ Icesi - Colombia
Universidad Icesi - Colombia |
| 14 | Beltran, Manuel A. Machado | - |
UNIV NACL COLOMBIA - Colombia
Universidad Nacional de Colombia - Colombia |
| 14 | Machado Beltrán, Manuel A. | - |
Universidad Nacional de Colombia - Colombia
|
| 15 | Alas, Lily Iracema Gordillo | - |
Minist Publ Hlth & Social Assistance - Guatemala
Ministry of Public Health and Social Assistance - Guatemala |
| 15 | Gordillo Alas, Lily Iracema | Mujer |
Ministry of Public Health and Social Assistance - Guatemala
Minist Publ Hlth & Social Assistance - Guatemala |
| 16 | Tablas, Lourdes Abigail Orellana | - |
Minist Publ Hlth & Social Assistance - Guatemala
Ministry of Public Health and Social Assistance - Guatemala |
| 16 | Orellana Tablas, Lourdes Abigail | - |
Ministry of Public Health and Social Assistance - Guatemala
Minist Publ Hlth & Social Assistance - Guatemala |
| 17 | Benko, Ria | - |
Univ Szeged - Hungría
Szegedi Tudományegyetem (SZTE) - Hungría |
| 18 | Convertino, Irma | Mujer |
Univ Pisa - Italia
Università di Pisa - Italia |
| 19 | Bonaso, Marco | Hombre |
Univ Pisa - Italia
Università di Pisa - Italia |
| 20 | Tuccori, Marco | Hombre |
Univ Pisa - Italia
Università di Pisa - Italia |
| 21 | Kirchmayer, Ursula | - |
Lazio Reg Hlth Serv - Italia
Department of Epidemiology Lazio Regional Health Service - Italia |
| 22 | Sanchez, Saul E. Contreras | - |
Mexican Inst Social Secur - México
Instituto Mexicano del Seguro Social - México |
| 22 | Contreras Sánchez, Saúl E. | - |
Instituto Mexicano del Seguro Social - México
|
| 23 | Rodriguez-Tanta, L. Yesenia | Mujer |
Univ Cient Sur - Perú
Universidad Científica del Sur - Perú |
| 24 | Aures, Ysabel Gutierrez | - |
Minist Hlth Peru - Perú
Ministerio de Salud, Lima - Perú |
| 24 | Gutierrez Aures, Ysabel | - |
Ministerio de Salud, Lima - Perú
Minist Hlth Peru - Perú |
| 25 | Lin, Boya | - |
UNIV FLORIDA - Estados Unidos
University of Florida - Estados Unidos |
| 26 | Alipour-Haris, Golnoosh | - |
UNIV FLORIDA - Estados Unidos
University of Florida - Estados Unidos |
| 27 | Eworuke, Efe | - |
IQVIA - Estados Unidos
IQVIA Inc. - Estados Unidos |
| 28 | Lopes, Luciane Cruz | Mujer |
Sorocaba Univ - Brasil
Universidade de Sorocaba - Brasil |
| Agradecimiento |
|---|
| We thank the valuable inputs of Juan Fernando Pineda and Andrea Vallejo from ICESI University -Colombia for their contribution in the collection of Colombian data. |
| We thank the valuable inputs of Juan Fernando Pineda and Andrea Vallejo from ICESI University-Colombia for their contribution in the collection of Colombian data. |