New drug approval is the process through which regulatory agencies authorize a new medicine for commercialization in a specific jurisdiction after thoroughly reviewing the quality, safety, and efficacy of the drug. The number of new molecules approved in a country is a powerful indicator of the degree of access to innovation in healthcare. In 2010, only three new molecules were approved in Mexico and that number has remarkably increased in the subsequent years with COFEPRIS leveraging strong pharmaceutical policies related to innovation promotion, international recognition, and continuous improvement.

Between 2012 and 2015, seven new drug packages were released accounting for 177 molecules, including five that were approved in Mexico for the first time in the world with prices turning out to be 24 to 74% lower than in the US. According to COFEPRIS, together these drugs cover 73% of the causes of death in Mexico, such as cardiovascular diseases, cancer, diabetes mellitus, and COPD as the main ones. The number of new molecules approved went down from 60 in 2012 to 41 and 32 in 2013 and 2014 respectively, and showed an upward trend in 2015 with 44 molecules. This is partially due to COFEPRIS sorting out the backlog it had in processing new drug submissions before 2011 resulting in 60 releases in 2012, and to the worldwide difficulties regarding drug innovation.

Number of new molecules approved by COFEPRIS (1)

Oncology drugs represented 20% of the 44 molecules approved in 2015, while both endocrinology/metabolism and respiratory made up 16% each. This clearly depicts a strong focus on chronic and degenerative diseases since acute diseases are no longer among the four main causes of death in Mexico and the development of new antibiotics is globally damped. In fact most new drugs in the infectology field are antiviral treatments for hepatitis C and HIV – both chronic infections in the edge of being cured.

Percentage of approved drugs by medical specialty in 2015 (1)

The year 2016 is expected to be very productive in terms of new drug approvals with high specialty drugs becoming the imminent focus of global biopharmaceutical companies, including immunotherapies and orphan drugs. As the Mexican pharmaceutical market grows and COFEPRIS positions itself as a reference regulatory agency in the region and the world, more companies will register new molecules in the country. Nevertheless, stakeholders should bear in mind that COFEPRIS approval is just the beginning of a much more complicated pathway incumbents need to follow to gain market access to public healthcare institutions, which buy 90% of high specialty drugs in the market.

This an excerpt of an analysis to be published in Mexico Health Review 2016. For more information visit http://mexicohealthreview.com and http://mexicohealthsummit.com the event in which the publication will be launched.

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