Mexico issues rules on biolimbos

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The Mexican regulatory body for approval of medicines, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), has issued rules for older non-originator biologicals registered prior to 19 October 2011, when the country’s guidelines for biocomparables were first published, mandating that companies conduct clinical trials to prove biosimilarity.

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For many years, Mexico lacked any specific regulation for biocomparables or indeed for any biological products. However, in 2009, the General Health Law was reformed to address the issue of biologicals by the inclusion of Article 222 bis in the Mexican Health Law [1].

Mexican guidelines for biocomparables came into force on 20 April 2012. However, Mexico has numerous non-originator biologicals, which came onto the market before these guidelines were issued by COFEPRIS. These products, known as ‘biolimbos’, have not undergone any marketing authorization review consistent with globally accepted standards for the approval of biosimilars.

In order to address this COFEPRIS issued a regulation in 2013, setting out tests and methods for drug interchangeability, including biosimilarity. The agency subsequently also issued a new Standard 257, allowing time for manufacturers of biolimbos already on the market to carry out the necessary biocomparability tests and meet new safety, efficacy and quality requirements.

The regulation, which took effect on 9 February 2015, affects the 23 non-originator biologicals that were registered on the Mexican market before the country’s guidelines for biocomparables were laid out [2]. The companies affected have until 31 December 2015 to present their tests to the agency.

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.

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

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Regulation of similar biotherapeutic products in Latin America

1.   GaBI Online - Generics and Biosimilars Initiative. Mexican guidelines forbiocomparables[]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 13]. Available from: 
2.   GaBI Online - Generics and Biosimilars Initiative. Mexicanbiocomparablesguidelines come into force []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 13]. Available from:

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