Moving forward: biologics and biocomparables in Mexico
Biological drugs and the legislation and regulation surrounding them are topics that have provided more than one headache to governments around the world. If the fight between innovators and generic companies over non-biological medicines has always been more a matter of industrial property, when a biological medicine is involved, regulatory concerns increase the complexity of the debate.
Biological medicines cannot be treated in the same way as non-biological medicines by the domestic health authorities, because the usual standards for safety, efficacy and quality are not suitable for proving that one particular biological medicine is a generic version of another, previously authorised one.
With these problems in mind, each country has been developing its own legislation. In some cases, domestic governments may follow what other countries are doing (the US, the EU, etc), but in the case of Mexico, the government, through the Ministry of Health and COFEPRIS (the department in charge of granting marketing authorisations for new drugs) has chosen the following solution.
A decree was published in October 2011 amending the General Health Law (LGS) and its regulations including new provisions for the approval of biologics and biocomparables. As well as providing definitions for both biological medicines (innovators) and biocomparables (generics), the main implications of the decree can be summarised in the following points:
