title: [Mexico recovers leadership on regulation of biosimilar biotech drugs].
abstract: Amid the epidemiological transition that Mexico is currently experiencing, an adequate access to biotech medicines is becoming very important. However, these medicines also involve new challenges for the sanitary authorities, given their higher complexity in structure and function than conventional chemical drugs. Consequently, it has been necessary to update the Mexican legal framework, which has placed Mexico at the forefront in this sector. This article describes briefly what biotech drugs are, why it has been necessary to regulate them differently, the evolution of the regulatory framework in Mexico, and the general features of the new system.
authors.affiliation: Práctica de Ciencias de la Vida, Tsuru Morales Isla Abogados, S.C., México. clopez@tmilaw.com.mx
authors.forename: Christian
authors.initials: C
authors.lastname: López Silva
mesh_terms: D001688:Biological Products / Q000592:standards*; D059451:Biosimilar Pharmaceuticals / Q000592:standards*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D007857:Leadership; D008800:Mexico
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals