Mexican Biosimilars Guideline

September 6, 2011 7:49 AM

The Mexican General Health Law was reformed on June 2009, by means of a decree to adapt the legal framework. With Article 222, an accurate definition of similar biotechnological products were given and they are called “biocomparables” in Mexico. This term was chosen to differentiate these products from the old so-called similar medicaments that had a strong background in the Mexican market which were considered as poor quality treatments (which have GMP approval but no bioequivalence testing).

With Article 222, general requirements to obtain the approval was given and besides, the provision to designate the same INN of the innovator product was included. But although the legislation was came into force in September 2009, the biosimilar pathway is still not published in Mexico and the exact requirements for licensing is not clear yet.

However, while there is no specific guidelines published, there are several biosimilars (actually biogenerics/copies) approved in Mexico. These products were developed and approved prior to the current “biosimilars” definition.

Currently, there are more than 20 similar biological products are on the Mexican market and these are divided in 4 main groups; epoetins, G-CSFs, human growth hormones and insulins. Besides, these so-called biosimilars are treated as interchangeable in Mexico.


Definition of biotechnological drugs
The article begins by providing a definition and indicating that drugs produced through molecular biotechnology are to be regulated. Other biologic products could be considered as excluded from this article.

Definition and allowance of biocomparable drugs
The definition of biocomparable drugs is new in itself, and it must be noted that:

1)      Reference to innovator 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 is not defined. From the article’s wording it would seem that clinical trials are necessary every time, and in vitro studies only on certain cases.

Lack of establishment/recognition of DPE rights
The issue of data package exclusivity (DPE) has not been defined in Mexico. Whereas confidentiality concerning data submitted to obtain drug marketing authorizations is recognized and protected by the health authorities, there is no specific legal or regulatory framework setting forth a non-reliance period, even though this is a North American Free Trade Agreement-derived obligation.

Drug substitution
The Article uses the same denomination and the same code as the Cuadro Basico de Medicamentos (the basic chart used by public entities to purchase drugs for the public health sector) for innovator and biocomparable drugs. The determination that innovator and biocomparable drugs are equal for the purpose of identification by name and public acquisition code purposes was taken by Congress after hearing arguments from the branded and generics industries.

This would, in principle, permit drug substitution in public acquisitions. The issue of drug substitution by physicians or pharmacists has not been addressed yet, but the pending regulations are expected to contain provisions in this regards.

The approval process
The Article makes reference to the New Molecules Committee, which was created through a regulatory reform in 2008, as the office in charge of determining the approval process for innovator drugs. The jurisdiction of this committee is broadened, as it is now entrusted with analyzing applications for both innovator biotechnological and biocomparables, including determining the amount and nature of the studies that will be required to approve the latter.

For this purpose, a Subcommittee of Evaluation of Biotechnological Products is created. The transitory provisions of the decree through which Article 222 bis was published mentions that this subcommittee must include member of Mexico’s two top public universities.




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