Original Article

Mexico at the vanguard: A new era in

medicines of biotechnological origin
Received (in revised form): 30th September 2009

Ernesto Saro Boardman

is Senator of the Republic for the State of Coahuila, Mexico where he is the Chairman of the Health Committee, a member of
the Municipal Development Committee, a member of the Committee on Urban Development and Planning and a member of the
Committee on Foreign Relations Non-Governmental Organizations. He graduated from ITESM (Tecnolgico de Monterrey) as a
Chemical Engineering Administrator in 1972. He was a Federal Representative from 2000 to 2002 and was Municipal President of
Ramos Arizpe, Coahuila between 19971999 and 20032005.

ABSTRACT This paper seeks to highlight Mexicos interest in being at the forefront in
Latin America and at the same time at the international level with the major players in the
field of biotech medicines. Mexico has just adopted an amendment to the General Health
Law that would allow the regulatory approval of biocomparable drugs (some countries refer
to these as biosimilar or biogeneric drugs). Such reform consists in the incorporation of
Article 222 Bis, which describes what is regarded as a biotechnology medicine, distinguishes
between innovative and biocomparable medicines, sets the requirements to obtain sanitary
registration and for marketing, describes the regulations regarding the pharmacovigilance
of these products, as well as the studies that are necessary to demonstrate the quality, safety
and efficacy of a biocomparable medicine which is supported with reference to an innovative
medicine, and taking into consideration the Opinion of the Committee of New Molecules
through the Subcommittee for the Evaluation of Biotechnology Products. This amendment
also includes the assignment of the same International Non-propriety Name (INN) as for
the reference product. The goal of the reform is to encourage competitiveness in Mexico by
regulating the manufacture and approval of these medicines making them more affordable
and hence fostering their access to the population.
Journal of Generic Medicines (2010) 7, 47. doi:10.1057/jgm.2009.38; published online 10 November 2009
Keywords: innovative biotechnological medicines; biocomparable medicines; amendment to Article
222 Bis of the general health law; access to biotech medicines at affordable prices

WHAT ARE
BIOTECHNOLOGICAL
MEDICINES?
Biotechnological medicines contain proteins
with very complex and unstable structures,
Correspondence: Ernesto Saro Boardman
Paseo de la Reforma 136, Torre Azul, Floor 15, Oficina A Col.
Jurez Del. Cuauhtmoc, CP 06600, Mexico, DF
E-mail: ernesto.saro@pan.senado.gob.mx

highly dependent on their production and

purification processes, so that minimal
changes in their process can cause variations
in the generation of immunological reactions.
The particular characteristics of medicines
of biotechnological origin have made it
necessary to have a special regime within
health regulations to specify their general
characteristics, as well as the clinical tests that
they will be subject to for their authorization.

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A new era in medicines of biotechnological origin

Owing to the novelty of these technologies

and products, their incorporation into the
pharmaceutical market has been conducted
through a precautionary principle, which
consists on a case-by-case assessment by
health authorities, since until recent years
there were only innovative medicines. This
has led to new criteria, rules and regulatory
procedures applicable to this type of
medicines, both at the level of the European
Medicines Agency and the Food and
Drug Administration of the United States.
Mexico has begun to lay the foundations to
progressively develop a regulation that is
harmonized with the regulatory framework
of the communities of countries with greater
development in this area.

NEGOTIATION AND
REGULATION IN MEXICO
Biotechnological medicines appeared almost
three decades ago and have revolutionized the
methods for treating serious diseases like
cancer. Mexico, in particular, has welcomed
the pharmaceutical industry for this purpose.
Although it is certain that these drugs are
highly effective for fighting against deadly
diseases, it is also true that they are the most
expensive drugs in the market, which makes
them inaccessible to the population, to such a
degree that the treatment for one person for
1 year can cost up to US$300.000.1
However, patents granted to the
manufacturers of biotechnology medicines
throughout this time have already begun to
expire, so competition of biocomparable
drugs should start providing consumers
greater access to these important but
expensive drugs. Before 2009, such
approvals were not regulated in the
Mexican legal system extending the facto
the patents of such products.
Given the technical complexity involved in
defining a legal process for the approval of
biocomparable medicines, scientists, academics,
physicians, health authorities, legislators,
representatives of national and international
industries were convened to participate in

various forums to address scientific, medical,

clinical and regulatory aspects, and to assess
the problems associated with the absence of
specific provisions to authorize this type of
medicines in our health legislation.
Mexican health regulations currently
allow only the approval of two types of
drugs: (a) innovative drugs, which are those
that comply with clinical trials; and (b) the
so-called interchangeable generics, which
demonstrate their safety and efficacy in terms
of their interchangeability with respect to
innovative products through bioequivalence
studies.
In the case of biotechnological medicines,
it is not possible to demonstrate in all cases
that a non-innovative medicine is identical to
the medicine of reference, as bioequivalence
studies are not applicable to this type of
medicines. Therefore, those non-innovative
biotechnological medicines have to submit
abbreviated clinical and pre-clinical tests,
which does not mean that these tests are less
strict. As it is not possible to predict the
immunological response derived from these
medicines, these tests have to be requested
based on the individual characteristics of each
product to verify their safety and efficacy.
Finally, after many meetings and
negotiations to incorporate into the Mexican
legal framework an adequate regulation for
these novel medicines, was adopted an
amendment to Article 222 Bis to the General
Health Law. This amendment was approved
in the Senate with 92 votes in favor, 3
abstentions and 0 votes against, and in the
Chamber of Deputies with 331 votes in
favor. Among other things the amendment
incorporates definitions that distinguish
between innovative biotechnological and
biocomparable medicines (those
biotechnological medicines approved through
an abbreviated approval process).
This new reform establishes that the Mexican
Federal Commission for the Protection
Against Sanitary Risks (COFEPRIS) shall
determine the requirements that are necessary
for these drugs to obtain their Sanitary

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Saro Boardman

Registration and be marketed, always taking

into consideration the opinion provided by
the Committee of New Molecules through
the Subcommittee for the Evaluation of
Biotechnology Products. Such subcommittee
is a body of consultation and support
integrated by at least five representatives of
the National Institute of Genomic Medicine,
the National Autonomous University of
Mexico and the National Polytechnic
Institute, in addition to the representation
of the health authorities and the General
Health Council. It will be responsible for
recommending to the Health Secretariat
(COFEPRIS) the clinical and pre-clinical
trials necessary and applicable to each
biocomparable medicine, with the aim of
ensuring on a case-by-case basis, that is to say
individually and in optimal conditions, their
safety and efficacy, their safe consumption
and hence their acceptance by physicians and
patients at a lower cost.
In addition, one important aspect that is
included in this reform is the one related to
pharmacovigilance, which requires including
in the labels the name of the manufacturer of
the biotechnological medicine and its origin,
the place of packaging and the importer; they
must also assign the same INN as to the
corresponding reference medicine.
The legislative reform to the General
Health Law is as follows:
Article 222 Bis for the purposes of this
Law, a biotechnology drug shall be any
substance that has been produced by
molecular biotechnology, that has a
therapeutic, preventive or rehabilitation
effect, that is presented in pharmaceutical
form, that is identified as such by its
pharmacological activity and its physical,
chemical and biological properties.
Innovative biotechnology drugs may be the
reference drugs for non-innovative
biotechnology drugs, which shall be known
as biocomparable drugs. The form of
identification of these products shall be
determined in the regulatory provisions.

In order to receive the sanitary registration

for biotechnology drugs, the applicant must
comply with the requirements and tests
that demonstrate the quality, safety and
efficacy of the product, in accordance with
the provisions of this Law, the regulations
and other applicable legal provisions, and
once the biotechnology drug is marketed,
it shall be necessary to subject it to
pharmacovigilance in accordance with the
corresponding norms.
The applicant of a sanitary registration for
biocomparable drugs that supports the
application on a reference biotechnology
drug must submit the clinical studies and,
when appropriate in vitro studies that are
necessary to demonstrate the safety, efficacy
and quality of the product.
In the case that the provisions regarding the
studies that are necessary and their
characteristics that are mentioned in this
article have not been issued, these shall be
determined on a product by product basis
taking into consideration the opinion of the
Committee of New Molecules which, for
the purposes of this article, shall have a
Subcommittee for the Evaluation of
Biotechnology Products that shall be made
up of specialists and scientists on
pharmaceutical biotechnology.
Biotechnology drugs shall include in their
labels the name of the manufacturer of
the biotech drug and its origin, the place it
was packed/bottled and if applicable the
importer, having to assign to it the same
INN as to the corresponding reference
drug, which shall not imply a separation in
the categories of the basic formulary and
catalogs of medicines of the health
institutions assigned to this purpose.

OUTLOOK FOR ACCESS

TO BIOTECHNOLOGICAL
MEDICINES
With this reform, Mexico has become a
pioneer by incorporating the issue of
biotechnological medicines in its health

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A new era in medicines of biotechnological origin

legislation, ensuring the safety and efficacy of

both innovative and biocomparable medicines;
making their availability for institutions,
physicians and patients both possible and
expedited; fostering the development of
pharmaceutical biotechnology in Mexico;
establishing clear rules for identifying the
products to provide greater certainty to
physicians who prescribe and to patients who
consume biotechnological medicines; as well
as ensuring the implementation of the existing
norms on pharmacovigilance for medicines.
Mexico has scientific, technical and
manufacturing capabilities in the field of
biotechnology, particularly in pharmaceutical
biotechnology, so it was a priority for
Mexican legislators to provide the private
sector and the government with the necessary

legal pathway for the approval of biocomparable

medicines. In this way, Mexico is positioned
to become the leading Latin American
pharmaceutical market in this area. Furthermore,
this effort reflects the concern of the Mexican
government to foster competition from
biocomparable medicines for the benefit of
the most disadvantaged. Competition among
manufacturers, increases the supply of
biotechnological medicines which should
inevitably result in the reduction of their
prices, given that their development requires
less clinical and pre-clinical tests, and as a
result, an easier access for the population.

REFERENCE
1. New York Times. (2008) When a drug costs
$300 000. Editorial 23 March.

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