Continuing with the series of articles on the management and implementation of the nomenclature of biological and biosimilar medicines in Brazil, Argentina, Mexico and Colombia, based on the publication of an extensive study carried out in Peru by Iglesias Galiano M in 2021, this article will provide a summary focused on Chile [1].
Both in Chile and in the other Latin American countries analysed, the Health Authorities in general have not adopted differentiated nomenclature criteria in the regulation for the authorization of biosimilar medicines.
Chile, based on international criteria and following the recommendations of the World Health Organization, issued in 2014 a regulatory framework for the authorization of biological and biosimilar medicines.
It is the National Agency for Medicines (Agencia Nacional de Medicamentos, ANAMED) in Chile through Technical Standard No. 170 of 2014, which regulates the health registration of biotechnological products derived from recombinant DNA techniques. It provides the tools for the authorization in the country of biosimilar biotechnological products that are as safe and effective as innovative drugs. However, this regulation does not provide any indication as to the nomenclature, and the same International Nonproprietary Name (INN) of the active substance is considered for both categories.
Table 1 contains a summary of the regulatory situation and nomenclature criteria for biological and biosimilar medicines in Chile.
| Table 1: Health regulation of the nomenclature of biologicals and biosimilars by ANAMED in Chile
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| Health regulation
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Nomenclature criteria
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| Technical Standard No. 170-2014
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– Does not issue guidance
– Maintains the same INN of the innovator biological medicine in authorized biological medicines
– Uses the term 'biosimilar'
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Data updated on 22 April 2022.
ANAMED: Agencia Nacional de Medicamentos; INN: International Nonproprietary Name.
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In Latin America, none of the countries selected in the study, including Chile, has implemented differentiated nomenclature criteria for authorized biosimilar medicines, maintaining the same international non-proprietary name of the innovator biologicals in authorized biosimilars [1].
Until the end of 2021, ANAMED has approved 14 biosimilars within the product classes of: 1) monoclonal antibodies; 2) granulocyte colony-stimulating factor; 3) insulin; 4) tumour necrosis factor (TNF) inhibitor for use in Chile [2].
This article is the fifth in a series of six articles on the nomenclature of biological and biosimilar medicines in various Latin American countries.
Related articles
Nomenclature of biologicals and biosimilars in Peru
Nomenclature of biologicals and biosimilars in Colombia
Nomenclature of biologicals and biocomparables in Mexico
Nomenclature of biologicals and biosimilars in Argentina
Nomenclature of biologicals and biosimilars in Brazil
| LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Nomenclatura de biológicos y biosimilares en Chile Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Nomenclatura de biológicos y biosimilares en Chile !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
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References
1. Iglesias Galiano, M. Situación de la nomenclatura de biológicos y biosimilares en países de referencia, países de la región y del Perú propuestas de implementación. 2021. DSpace Repository. 2021.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Chile [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 22]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-chile
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