The guidelines, which were published in the Mexican Government’s official journal (Diaro Oficial de la Federación) on 19 October 2011 cover requirements for pre-clinical, clinical and other analyses that should be used to demonstrate the safety, quality and effectiveness of the biosimilar, or ‘biocomparable’, as they are termed in Mexico, in comparison to the reference biological. The guidelines also point to studies being required for immunogenicity and adverse events, as well as demonstration of the same mechanism of action or that the biocomparable presents the same pharmacodynamic effect as the reference biological. It is mentioned that once the biocomparable has demonstrated physicochemical comparability then the scope of clinical trials required for registration can be reduced.

Biocomparables should not be confused with ‘similares’ in Mexico, which are described as ‘copies of small molecule generics that have not undergone bioequivalence testing’.

Although Mexico has only just established formal regulatory guidelines for the approval of ‘biocomparables’, non-originator biologicals have been on the market in Mexico for several years, according to Decision Resources Analyst Lulu Pickering. In fact in 2011 there were 23 biocomparables registered on the Mexican market.

For example, Probiomed already sells six non-originator biologicals including Kikuzubam (rituximab), which is Probiomed’s version of Roche’s Rituxan/MabThera (rituximab). In April 2012, just before the new biocomparables guidelines took effect in Mexico, Probiomed won a US$14.4 million tender to provide Kikuzubam to the State Employees’ Social Security and Social Services. Institute (ISSSTE). However, owing to the existing patents for Rituxan/MabThera, Roche remains engaged in litigation against Probiomed.

The guidelines are, however, somewhat brief, and it is hoped that they will be expanded or additional guidance will be provided, which will provide further explanation of the requirements for regulatory approval of biocomparables in Mexico.

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