Following the articles on the management and implementation of the nomenclature of biological and biosimilar medicines in Brazil and Argentina based on the study by Iglesias Galiano M. 2021, this article will provide a summary of the same in Mexico.
Biocomparables (known as biosimilars in other countries) have a very important role in promoting the sustainability of health systems, not only in Mexico but worldwide, implying significant savings for patients, payers and health institutions as well as market opening, which provides a fair competitive ground.
In Mexico, the regulatory body for drug approval is the Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). COFEPRIS, which implemented the health regulation for the authorization of biotechnological drugs as of 2012, uses the terminology of biocomparables for off-patent biologicals that have opted for the comparability approval pathway [1, 2].
In Mexico, therefore, biocomparables are referred to comparable biotechnology drugs and these should not be confused with the so-called ‘similar’ drugs, which are described as ‘copies of small molecule generics that have not been subjected to bioequivalence testing’ [2].
Currently, in Mexico and in other Latin American countries, both innovator biological drugs and authorized biocomparable drugs are marketed and distributed with the same International Nonproprietary Name (INN) of the active substance, see Table 1.
If the products are on the list of essential drugs, this administrative process, regulated by the Secretariat of Health under the General Council of Health, favours these products to be interchanged indiscriminately in order to facilitate competitive supply and demand, or availability of the drug. However, the latter is problematic in clinical terms, especially with regard to traceability [3].
| Table 1: Health regulation of the nomenclature of biologicals and biocomparables by COFEPRIS in Mexico
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| Health regulation
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Nomenclature criteria
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NOM-EM-001-SSA1-2012
NOM-177-SSA1-2013
NOM-257-SSA1-2014
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– Does not issue guidelines
– Maintains the same INN of the innovator biological medicine in authorized biological medicines
– Uses the term 'biocomparable’
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Data updated on 18 March 2022.
COFEPRIS: Comisión Federal para la Protección contra Riesgos Sanitarios; INN:International Nonproprietary Name.
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In Mexico, in general terms, the country's health authority has not adopted differentiated nomenclature criteria in the regulation for the authorization of biocomparables.
There are currently 13 biocomparables approved in Mexico [4].
This article is the third in a series of articles on the nomenclature of biological and biosimilar medicines in various Latin American countries.
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| 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 biocomparables en México 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 biocomparables en México !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.
2. GaBI Online – Mexican guidelines for biocomparables [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 18]. Available from:
www.gabionline.net/guidelines/Mexican-guidelines-for-biocomparables
3. Xibille D, Carrillo S, Huerta-Sil G, et al. Current state of biosimilars in Mexico: the position of the Mexican College of Rheumatology, 2016. Reumatol Clin [Engl Ed]. 2018;14(3):127-36.
4. GaBI Online - Generics and Biosimilars Initiative. Biocomparables approved in Mexico [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 18].
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