Nomenclature of biologicals and biocomparables in Mexico

Home/Policies & Legislation | Posted 18/03/2022 post-comment0 Post your comment

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.

Naming 3 V13J04

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
Health regulation Nomenclature criteria
NOM-EM-001-SSA1-2012
NOM-177-SSA1-2013
NOM-257-SSA1-2014
– Does not issue guidelines
– Maintains the same INN of the innovator biological medicine in authorized biological medicines
– Uses the term 'biocomparable’
Data updated on 18 March 2022.
COFEPRIS: Comisión Federal para la Protección contra Riesgos Sanitarios; INN:International Nonproprietary Name.

 

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.

Related articles
Nomenclature of biologicals and biosimilars in Argentina

Nomenclature of biologicals and biosimilars in Brazil

AMD position statement on the use of biocomparables for psoriasis

Mexico introduces new decree on health regulation

A new decree modifies several aspects of the regulatory approval system for biosimilars in Mexico

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. 

  

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].

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
PDUFA VI: FDA could promote generics competition
47 MD001813
Home/Policies & Legislation Posted 29/07/2022
House bill passes FDA funding fees but conflicts with Senate bill
User Fee V13H23
Home/Policies & Legislation Posted 15/07/2022
US Senate clarifies status of interchangeable biosimilar exclusivity
Interchangeability V18K30
Home/Policies & Legislation Posted 27/05/2022
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010