When talking about allopathic medicines, it is well known that the Pharmaceutical Industry in Mexico does not carry on research and development in primary molecules but only on secondary molecules, i.e. formulations of two or more active ingredients – known molecules -, which combination results in a second medical use, or which enhances the therapeutic effect thereof. Said formulations can be lawfully protected by a patent, provided that they comply with the patentability requirements of the Law.
Additionally, the Mexican pharmaceutical industry possesses the infrastructure - facilities and experience - to manufacture generics. As well, the legal framework has established the rules for their introduction in the pharmaceutical market.
It is important to note that the current introduction of innovative medicaments into the pharmaceutical market, which are obtained by biotechnology techniques, has increased.
Biotech molecules, or biologics, are high molecular weight proteins with a size of up to 1000 times than that of chemically synthesized molecules. They can be recombinant proteins, monoclonal antibodies, vectors for the transport of genetic material, fragments of an antibody, nucleic acids, antisense oligonucleotides, etc.
Unlike traditional drugs obtained from conventional chemical synthesis, biotech drugs are obtained from processes that can last for months and that commonly involve several complex stages. This complexity makes the target molecule totally dependent of the manufacturing process, on each of the stages. Therefore, small changes in the whole process could be clinically significant in terms of safety and efficacy of the final product. It is for this reason that in biotechnology it is said that the product is the process because of this total dependence of biotech drugs on every single step of their manufacturing process.
Just like generics for allopathic medicines, biosimilars for biotechnological medicines exist, which, as their name suggest, are similar but not exactly identical to the reference innovative products. These were until recently also called biogenerics, in analogy to generics of allopathic medicines, but the term biosmilar is the most frequently used.
The Mexican pharmaceutical industry faces different issues regarding the production of biosimilar drugs. One of the problems that arise when the biosimilar is compared with the reference innovative drug is how to determine the biosimilarity between both. There are in vitro tests available that evaluate structural aspects, among other parameters, but that do not reproduce the biological activity in vivo of the biosimilar. Therefrom, the resulting information cannot be extrapolated to predict the biosimilar activity in a human being. As already mentioned, the research of biosimilar drugs involves a much more complex process than the research of traditional generics do. This translates into much higher costs of obtaining the drug through chemical synthesis, both in terms of time and money.
Mexico is delayed in the issuance of efficient regulations that allow the entry of innovative biotech drugs, and therefore, their entry into market, by conducting relevant clinical studies and provided that they have demonstrated their safety and effectiveness, and that they are biosimilars generated from the innovative drugs of reference through studies and tests of comparability.
Finally, it is essential to have the legal framework that includes all provisions to give certainty, on the one hand, to pharmaceutical companies about the requirements to comply with in order to obtain the health approval for a biosimilar, and in a second hand, certainty to the Mexican people that this biosimilar will be highly effective and safe in the treatment of diseases for which they were developed.
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