Title
Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective
Date Issued
01 July 2022
Access level
metadata only access
Resource Type
review
Author(s)
Teran E.
Hannois D.
Lema M.
Mantilla W.
Rico-Restrepo M.
McElwee E.
Castro Sanchez N.
Valdivieso N.
Espinoza M.A.
Publisher(s)
Elsevier Ltd
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.
Start page
e348
End page
e358
Volume
23
Issue
7
Language
English
OCDE Knowledge area
Oncología Farmacología, Farmacia
Scopus EID
2-s2.0-85133216554
PubMed ID
Source
The Lancet Oncology
ISSN of the container
14702045
Sponsor(s)
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.
Sources of information: Directorio de Producción Científica Scopus