Mexican universities and research centers authorized as third parties to test biotech drugs
In an unprecedented move, the Mexican Health Authority (COFEPRIS) has authorized a university and two research centers as third parties to perform the characterization tests and preclinical studies needed to demonstrate the biosimilarity of biotech drugs submitted to COFEPRIS.
In order to formalize this alliance, COFEPRIS has signed cooperation agreements with the National Autonomous University of Mexico (UNAM), the National Polytechnic Institute (IPN) and the Center for Research and Assistance in Technology and Design of the State of Jalisco (CIATEJ).
The inclusion of these institutions to the model of authorized third parties will allow the pharmaceutical industry to ask for scientific-technical support regarding the tests requested by COFEPRIS during the biotech drugs authorization process.
This decision has been made within the framework of the “Strategy for the implementation of the regulation of biotech drugs in Mexico,” that resulted in the publication of Regulation 257, which entered into force in February 2015, as reported here.
COFEPRIS informed that biotech drugs currently represent between 10 and 15 percent of the national pharma market, and it is estimated to increase to 45 percent in 2016.