The regulatory body for approval of medicines in Mexico is the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). The agency is a decentralised organ of the Department of Health with technical, administrative and operational autonomy, is responsible for protecting the Mexican population against sanitary risks, through sanitary regulation, control and promotion.
For many years, Mexico lacked any specific regulation for biosimilars or indeed for 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 biosimilar drugs as ‘biocomparable’ drugs in Mexico and allows for the following differences compared to originator biologicals:
- Reference to innovator drugs is allowed for the authorisation of biocomparables.
- 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 andin vitrostudies 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
http://dof.gob.mx/nota_detalle.php?codigo=5214882&fecha=19/10/2011
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 biosimilars (or non-originator biologicals) registered on the Mexican market. This number is expected to swell following the patent expiries of 10 global biological blockbusters during 2012.
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Source: www.gabionline.net
