TY - JOUR
T1 - Medicamentos biocomparables en México
T2 - La postura del Colegio Mexicano de Reumatología, 2012
AU - Espinosa Morales, Rolando
AU - Díaz Borjón, Alejandro
AU - Barile Fabris, Leonor Adriana
AU - Esquivel Valerio, Jorge Antonio
AU - Medrano Ramírez, Gabriel
AU - Arce Salinas, César Alejandro
AU - Barreira Mercado, Eduardo Rubén
AU - Cardiel Ríos, Mario Humberto
AU - Díaz Jouanen, Efraín
AU - Flores Murrieta, Francisco Javier
AU - Fraga Mouret, Antonio
AU - Garza Elizondo, Mario Alberto
AU - Luján Estrada, Miguel
AU - Muñoz Barradas, Francisco José
AU - Talavera Piña, Juan Osvaldo
AU - Vera Lastra, Olga Lidia
PY - 2013/3
Y1 - 2013/3
N2 - 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 registry 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.
AB - 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 registry 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.
KW - Biocomparable
KW - Biologic
KW - Biosimilar
KW - Biotechnological
KW - Innovator drugs
KW - Rheumatoid arthritis
UR - http://www.scopus.com/inward/record.url?scp=84875377912&partnerID=8YFLogxK
U2 - 10.1016/j.reuma.2012.11.001
DO - 10.1016/j.reuma.2012.11.001
M3 - Artículo
SN - 1699-258X
VL - 9
SP - 113
EP - 116
JO - Reumatologia Clinica
JF - Reumatologia Clinica
IS - 2
ER -