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Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective
Indexado
WoS WOS:000833519600012
Scopus SCOPUS_ID:85133216554
DOI 10.1016/S1470-2045(22)00121-8
Año 2022
Tipo revisión

Citas Totales

Autores Afiliación Chile

Instituciones Chile

% Participación
Internacional

Autores
Afiliación Extranjera

Instituciones
Extranjeras


Abstract



In a multiday conference, a panel of Latin American experts in biological cancer therapies and health economics were provided with questions to address the barriers restricting access to biosimilars in Latin America, specifically for patients with breast cancer and colorectal cancer, for whom biosimilars can be a path forward to increasing access to care. During the conference, responses were discussed and edited until a consensus was achieved. The regulatory challenges identified in the conference included heterogenous regulations, non-adherence to regulatory pathways, scarcity of market opportunity, inadequate naming of biosimilars by only using international non-proprietary names, imprecise use of interchangeability and substitution, and insufficient traceability and pharmacovigilance. Recommendations were developed to improve the implementation of regulatory pathways and reliable procurement strategies that increase access to these therapies with adequate traceability and outcome measures; efforts from all involved stakeholders will be crucial. These recommendations can serve as a strategy for biosimilar adoption in other countries in a similar situation.

Revista



Revista ISSN
Lancet Oncology 1470-2045

Métricas Externas



PlumX Altmetric Dimensions

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Disciplinas de Investigación



WOS
Oncology
Scopus
Sin Disciplinas
SciELO
Sin Disciplinas

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Publicaciones WoS (Ediciones: ISSHP, ISTP, AHCI, SSCI, SCI), Scopus, SciELO Chile.

Colaboración Institucional



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Autores - Afiliación



Ord. Autor Género Institución - País
1 Teran, Enrique Hombre Universidad San Francisco de Quito - Ecuador
Univ San Francisco Quito - Ecuador
2 Gómez, Henry Hombre Instituto Nacional de Enfermedades Neoplasicas - Perú
Inst Nacl Enfermedades Neoplas - Perú
3 Hannois, Damian Hombre Clínica INDISA - Chile
4 Lema, Mauricio Hombre Clínica de Oncología ASTORGA - Colombia
Clin Oncol Astorga - Colombia
5 Armando Mantilla, William Hombre Universidad del Rosario - Colombia
Univ Rosario - Colombia
6 Rico-Restrepo, Mariana Mujer America University Foundation - Colombia
Amer Hlth Fdn - Colombia
Americas Health Foundation (AHF) - Estados Unidos
Americas Health Foundation - Estados Unidos
Americas Health Foundation - Colombia
7 McElwee, Elizabeth Mujer Americas Health Foundation (AHF) - Estados Unidos
Amer Hlth Fdn - Colombia
Amer Hlth Fdn - Estados Unidos
Americas Health Foundation - Estados Unidos
8 Castro Sanchez, Noe - Universidad San Carlos de Guatemala - Guatemala
8 Sanchez, Noe Castro Mujer Univ San Carlos - Guatemala
Universidad San Carlos de Guatemala - Guatemala
9 Valdivieso, Natalia Mujer Instituto Nacional de Enfermedades Neoplasicas - Perú
Inst Nacl Enfermedades Neoplas - Perú
10 ESPINOZA-SEPULVEDA, MANUEL ANTONIO Hombre Pontificia Universidad Católica de Chile - Chile

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Financiamiento



Fuente
Fondo Nacional de Desarrollo Científico y Tecnológico
World Health Organization
Abbott Laboratories
Pfizer
Amgen
Meso Scale Diagnostics
Boehringer Ingelheim
Merck
Abbott
United Nations Development Programme
Roche
LivaNova
Agencia Nacional de Investigación y Desarrollo
Asociación Chilena para el estudio del dolor

Muestra la fuente de financiamiento declarada en la publicación.

Agradecimientos



Agradecimiento
This manuscript was supported by an unrestricted grant provided by Abbott given to the Americas Health Foundation, a 501(c)3 non-profit organisation dedicated to improving health care throughout the Latin American region. Americas Health Foundation independently selected the panel members and developed the questions provided to the members of the panel. The contents of the manuscript are a reflection of the authors’ expertise and Abbott did not have any influence or say in the contents or development of the manuscript.
This manuscript was supported by an unrestricted grant provided by Abbott given to the Americas Health Foundation, a 501(c)3 non-profit organisation dedicated to improving health care throughout the Latin American region. Americas Health Foundation independently selected the panel members and developed the questions provided to the members of the panel. The contents of the manuscript are a reflection of the authors’ expertise and Abbott did not have any influence or say in the contents or development of the manuscript.
This manuscript was supported by an unrestricted grant provided by Abbott given to the Americas Health Foundation, a 501 (c) 3 non-profit organisation dedicated to improving health care throughout the Latin American region. Americas Health Foundation independently selected the panel members and developed the questions provided to the members of the panel. The contents of the manuscript are a reflection of the authors? expertise and Abbott did not have any influence or say in the contents or development of the manuscript.

Muestra la fuente de financiamiento declarada en la publicación.