Biosimilar Drugs in Mexico: Position of the Mexican College of Rheumatology, 2012

Biotechnological drugs (BTDs) are complex molecules whose manufacturing process precludes the ability to identically reproduce the structure of the original product, and therefore there cannot be an absolute equivalence between the original (innovative) medication and its biosimilar counterpart. BTD...

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Published in:Reumatología clinica (Barcelona) 2013-03, Vol.9 (2), p.113-116
Main Authors: Espinosa Morales, Rolando, Díaz Borjón, Alejandro, Barile Fabris, Leonor Adriana, Esquivel Valerio, Jorge Antonio, Medrano Ramírez, Gabriel, Arce Salinas, César Alejandro, Barreira Mercado, Eduardo Rubén, Cardiel Ríos, Mario Humberto, Díaz Jouanen, Efraín, Flores Murrieta, Francisco Javier, Fraga Mouret, Antonio, Garza Elizondo, Mario Alberto, Luján Estrada, Miguel, Muñoz Barradas, Francisco José, Talavera Piña, Juan Osvaldo, Vera Lastra, Olga Lidia
Format: Article
Language:English
Subjects:
Artritis Reumatoide
Biocomparable
Biologic
Biológicos
Biosimilar
Biotechnological
Biotecnológicos
Fármacos innovadores
Innovator drugs
Rheumatoid arthritis
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Summary:Biotechnological drugs (BTDs) are complex molecules whose manufacturing process precludes the ability to identically reproduce the structure of the original product, and therefore there cannot be an absolute equivalence between the original (innovative) medication and its biosimilar counterpart. BTDs have been proven useful in the treatment of several rheumatic diseases; however, their high cost has prevented their use in many patients. Several BTD patents have expired or are close to expire, triggering the development of structurally similar drugs with efficacy and safety profiles comparable to the innovative compound; however, these must be evaluated through evidence-based medicine. The Mexican General Health Law contemplates the registration of these biosimilar drugs for their use in our country. This document is a forethought from members of the Mexican College of Rheumatology, pharmacologists, and epidemiologists, in accordance with Mexican health authorities regarding the necessary scientific evidence required to evaluate the efficacy and safety of biosimilar drugs before and after their arrival to the Mexican market. Los medicamentos biotecnológicos (MBT) son moléculas complejas cuyo proceso de elaboración impide replicar con gran exactitud la substancia original, por lo que no existe una equivalencia absoluta entre la droga original (innovador) y el biocomparable. Los MBT han probado su eficacia en diversas patologías reumáticas, aunque su alto costo impide su utilización en muchos pacientes. Diversas patentes de medicamentos biotecnológicos han expirado o expiraran próximamente, detonando así el desarrollo de fármacos estructuralmente similares y probablemente con eficacia y seguridad comparable a los medicamentos innovadores, aunque estas características deben ser probadas. La Ley General de Salud Mexicana actual contempla el registro de estos medicamentos para su utilización en nuestro país. Este documento, es una reflexión de miembros del Colegio Mexicano de Reumatología, farmacólogos e investigadores en epidemiología, en conjunción con nuestras autoridades sanitarias, sobre los estudios científicos necesarios de los biocomparables previos y posterior a su incursión en el mercado mexicano.
ISSN:2173-5743
2173-5743
DOI:10.1016/j.reumae.2012.11.003