Mexican guidelines for biocomparables

INICIO/Directrices | Posted 10/02/2012 post-comment0 Post your comment

Last update:  27 March 2015

The regulatory body for approval of medicines in Mexico is the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). The agency is a decentralized organ of the Department of Health with technical, administrative and operational autonomy. The agency is responsible for protecting the Mexican population against sanitary risks, through sanitary regulation, control and promotion.

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For many years, Mexico lacked any specific regulation for non-originator biologicals or indeed for any biological products. Although these products were available for patients in the Mexico, their approval by COFEPRIS was made under the general statutory framework for chemical drugs.

The General Health Law was reformed on 11 June 2009, by means of a decree to adapt the legal framework. This addressed the issue of biologicals by the inclusion of Article 222 bis in the Mexican Health Law. Although this only acts as the legal basis for more thorough legislation – which will come with the publication of regulations – it is a step in the right direction for Mexico.

The amendment defines non-originator biologicals drugs as biocomparables in Mexico and allows for the following differences compared to originator biologicals:

  1. Reference to originator drugs is allowed for the authorization of biocomparables.
  2. The nature and amount of studies that will be necessary for the approval of biocomparable drugs are not defined. From the article’s wording it would appear that clinical trials are always necessary and in vitro studies are only necessary if required to demonstrate the safety, effectiveness and quality of the product.

Biocomparables should not be confused with ‘similares’ in Mexico, which are described as ‘copies of small molecule generics that have not undergone bioequivalence testing’.

COFEPRIS published guidance for biocomparables in the Mexican Government’s official journal, Diaro Oficial de la Federación, on 19 October 2011. These guidelines came into force on 20 April 2012.

Overarching Guidelines
These guidelines cover all biosimilar products:

DECREE by which amends and adds various provisions of the regulation of health supplies
Effective date: 20 April 2012

According to the new guidelines a company can submit a dossier for approval of a biocomparable to COFEPRIS eight years prior to expiration of the patent on the originator biological, however, final approval for the biocomparable will only be granted at the end of the term of the patent.

Despite the fact that Mexico has only just established formal regulatory guidelines, in 2011 there were already 23 non-originator biologicals registered on the Mexican market. The number of biocomparables in Mexico is expected to swell following the patent expiries of 10 global biological blockbusters during 2012.

COFEPRIS issued a regulation in 2013, which took effect on 9 February 2015, for older non-originator biologicals, known as ‘biolimbos’, registered prior to 19 October 2011. The regulation sets out tests and methods for drug interchangeability, biocomparability tests and new safety, efficacy and quality requirements [1].

If you would like to receive a copy* of the Mexican Health Law containing Article 222 bis, please send us an email.

*For profit organizations subjected to a fee

Editor’s comment
It should be noted that biocomparables approved in Mexico might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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1.  GaBI Online - Generics and Biosimilars Initiative. Mexico issues rules on biolimbos []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 27]. Available from:

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