1. Biosimilar Drugs in Mexico: Position of the Mexican College of Rheumatology, 2012.
- Author
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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, Estrada, Miguel Luján, Muñoz Barradas, Francisco José, Talavera Piña, Juan Osvaldo, and Vera Lastra, Olga Lidia
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PHARMACEUTICAL biotechnology , *RHEUMATOLOGY , *DRUG factories , *MEDICAL innovations , *MEDICAL care costs , *RHEUMATISM treatment - Abstract
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. [ABSTRACT FROM AUTHOR]
- Published
- 2013
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