Last update: 22 July 2022
The regulatory body for approval of medicines in Mexico is the Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). The agency, created in 2001, is a decentralized organ of the Department of Health with technical, administrative and operational autonomy. It is responsible for protecting the Mexican population against sanitary risks, through sanitary regulation, control and promotion.
In Mexico, biological products with expired patents are known as biotechnological biocomparable medicines. The regulatory body in charge of approving biocomparables is COFEPRIS.
COFEPRIS is a decentralised body of the Ministry of Health (SSA), with technical, administrative and operational autonomy, created in 2001 to be in charge of the country's health control and regulation, which was previously exercised by the former Under-Secretariat of Regulation and Health Promotion of the SSA.
The SSA is the agency of the Executive Branch that is primarily responsible for disease prevention and health promotion of the population and establishes State policies so that the population can exercise its right to health protection.
For many years, Mexico lacked any specific regulation for non-originator biologicals or indeed for biological products. Although these products were available for patients in 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. The Article 222 bis defined biocomparable as non-originator/ innovator biological that has demonstrated to have comparable quality, efficacy and safety to the reference product. Article 222 also establishes the legal basis for the registration of biocomparable 
The amendment defines biosimilar drugs as ‘biocomparable’ drugs in Mexico and allows for the following differences compared to originator biologicals:
1. Reference to innovator drugs is allowed for the authorisation of biocomparables.
2. The nature and number 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.
On 11 December 2014, the Mexican Government’s official journal (Diaro Oficial de la Federación) published the Mexican Norm 257 of the Ministry of Health on biotechnological medicines. This Norm came into force on 9 February 2015 with clear legal framework for the authorisation of biotechnological innovator and biocomparable products, which places Mexico at forefront in Latin America in this field. The objectives include:
1. The general operating guidelines for the evaluation of the technical and scientific information submitted during the application process for the registration of biotechnological medicines.
2. The criteria by which the Ministry will conduct the regularisation process for biotechnological medicines.
3. The general specifications for the control of the production of biotechnological medicines.
4. The procedure for the authorisation of clinical trials protocols of biotechnological medicines.
5. The specifications that biotechnological medicines must comply with in order to be recognised as reference biotechnological medicines.
In addition, the technical requirements for biocomparability are described in the Official Mexican Norms 177 and 220. Norm 177 establishes the tests and procedures to demonstrate that a medicine is interchangeable and the requirements that the Authorised Third Parties must adhere when performing the tests for interchangeability. Norm 220 establishes the guidelines for the implementation and operation of pharmacovigilance in the national territory.
Biocomparables should not be confused with ‘similares’ in Mexico, which are described as ‘copies of small molecule generics that have not undergone bioequivalence testing’. There are currently available 13 biocomparables with a health registry number .
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.
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
Official Mexican NORM NOM-257-SSA1-2014 with regard to biosimilars
Effective date: 9 February 2015
Official Mexican NORM NOM-177-SSA1-2-13, Establishing tests and procedures to demonstrate that a medicine is interchangeable. Requirements to which Third Parties that perform interchangeable tests, must be subjected to. Requirements to perform biocomparability studies. Requirements to which Authorised Third Parties, Research Centres or Hospital Institutions that perform biocomparability tests, must be subjected to
Effective date: 6 May 2013
Official Mexican NORM NOM-220-SSA1-2016, Implementation and pharmacovigilance procedure
Effective date: 15 January 2018
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 established formal regulatory guidelines in early 2012, there were already 23 non-originator biologicals registered on the Mexican market in 2011. 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 .
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
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 but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘biocomparables’ approved in Mexico might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
Mexican biocomparables guidelines come into force
EMA to revise overarching biosimilar guidelines
EMA plans to revise biosimilar guidelines
EU guidelines for biosimilars
EMA adopts guideline on biosimilar monoclonal antibodies
The current EU regulatory framework governing biosimilars
Regulatory recommendations for biosimilars in the EU
1. GaBI Online - Generics and Biosimilars Initiative. Mexico issues rules on biolimbos [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International [cited 2015 Mar 27]. Available from: www.gabionline.net/Guidelines/Mexico-issues-rules-on-biolimbos
2. GaBI Online - Generics and Biosimilars Initiative. Biocomparables approved in Mexico [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International [cited Jul 22]. Available from: www.gabionline.net/biosimilars/general/biocomparables-approved-in-mexico
3. GaBI Online - Generics and Biosimilars Initiative. Mexican biocomparables guidelines come into force [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International [cited 2022 Jul 22]. Available from: www.gabionline.net/Guidelines/Mexican-biocomparables-guidelines-come-into-force
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