Mexico at the Vanguard: A New Era in Medicines of Biotechnological Origin

Abstract

This paper seeks to highlight Mexico's interest in being at the forefront in Latin America and at the same time at the international level with the major players in the field of biotech medicines. Mexico has just adopted an amendment to the General Health Law that would allow the regulatory approval of biocomparable drugs (some countries refer to these as biosimilar or biogeneric drugs). Such reform consists in the incorporation of Article 222 Bis, which describes what is regarded as a biotechnology medicine, distinguishes between innovative and biocomparable medicines, sets the requirements to obtain sanitary registration and for marketing, describes the regulations regarding the pharmacovigilance of these products, as well as the studies that are necessary to demonstrate the quality, safety and efficacy of a biocomparable medicine which is supported with reference to an innovative medicine, and taking into consideration the Opinion of the Committee of New Molecules through the Subcommittee for the Evaluation of Biotechnology Products. This amendment also includes the assignment of the same International Non-propriety Name (INN) as for the reference product. The goal of the reform is to encourage competitiveness in Mexico by regulating the manufacture and approval of these medicines making them more affordable and hence fostering their access to the population.