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...