With the discovery and introduction of biotechnological drugs, the pharmaceutical industry is rapidly rising, changing and expanding. Biotechnological drugs are much more complex than chemically synthesized drugs. They contain bioactive substances with very complex structures. When these substances are consumed, their biological activity is highly dependent on their production and purification processes. Accordingly, minimal changes in their process or formulation, which happen when manufacturing biosimilar drugs, can cause variations in their safety and may even generate immune reactions against the drug from the original manufacturer.
As patents covering biotechnological drugs started expiring, the mentioned complexity aspect of these drugs has raised concern on the convenience of keeping the testing of these drugs at the same level than that of chemical drugs. Even the convenience of keeping the same International Non-proprietary Name (INN) has been questioned. Governments all over the world are now in the imperative need to establish special rules to properly control the surrounding circumstances of biotechnological drugs, and Mexico is pioneering this process as will be described below.
The General Health Law was reformed on June 11, 2009, by means of a decree to adapt the legal framework. Such reform consists in the incorporation of article 222 bis, providing therefore a more accurate definition of biotechnological drugs and giving birth to the so-called biocomparable drugs which are somehow based on the information of a reference biotechnological drug when applying to a sanitary approval provided that they demonstrate security, efficacy and quality of the product according through presenting the clinical studies for that purpose. Biocomparable is the term given to biosimilar drugs to avoid confusion with the formerly so-called similar medicaments that had a strong presence in the Mexican market and have been considered as poor quality medicaments. Article 222 bis also establishes general requirements to obtain sanitary approval cases, and it includes the provision to designate the same INN of a reference product to a biocomparable.
The decree came into force on September 8, 2009, and the Ministry of Health had a 180-day period to issue all the specific regulations pertaining to the approval of biocomparables. The deadline was not complied with, but the specific regulations have been closed for public consultation and the final rules are expected to be published soon. Article 222 bis states, as well, that innovative biotechnological drugs may be used as a reference for biocomparables, and that the way of identifying the non-innovative drugs will be determined in further regulations, in which the role of the so-called New Molecules Committee will be crucial.
Contrariwise to chemical Generic Drugs, it has been suggested that there are biotechnological drugs that despite being different to a reference drug, could be considered similar or comparable because they show the same results as the reference biotechnological drug in different patients. This could imply that it may be possible to refer to clinical data of a patented biotechnological drug as reference for this kind of biocomparables. For the Mexican case, it seems that the pending specific regulations are going to state that the level of similarity to the innovative biotechnological drug of a biocomparable drug will be evaluated on a case-by-case basis, which give uncertainty to all players. Therefore, the role of broad claims in the protection of biotechnology drugs is becoming increasingly important.
All of the above facts will have several and uncertain repercussions in the Mexican practice, including the so-called linkage system and the data exclusivity issues, since the criteria that would be established on the pending regulations seem to be relying on a case-by-case philosophy. In the years to come, however, a system that provides protection of these rights while promoting a fair market competition and a broad exploitation of biotechnology drugs upon expiry of patents must be built.
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