title: Biosimilar drugs in Mexico: position of the Mexican College of Rheumatology, 2012.
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 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.
authors: Instituto Nacional de Rehabilitación, Secretaría de Salud, Ciudad de México, México. rolespi@yahoo.com
authors: Rolando
authors: R
authors: Espinosa Morales
authors: Alejandro
authors: A
authors: Díaz Borjón
authors: Leonor Adriana
authors: LA
authors: Barile Fabris
authors: Jorge Antonio
authors: JA
authors: Esquivel Valerio
authors: Gabriel
authors: G
authors: Medrano Ramírez
authors: César Alejandro
authors: CA
authors: Arce Salinas
authors: Eduardo Rubén
authors: ER
authors: Barreira Mercado
authors: Mario Humberto
authors: MH
authors: Cardiel Ríos
authors: Efraín
authors: E
authors: Díaz Jouanen
authors: Francisco Javier
authors: FJ
authors: Flores Murrieta
authors: Antonio
authors: A
authors: Fraga Mouret
authors: Mario Alberto
authors: MA
authors: Garza Elizondo
authors: Miguel
authors: M
authors: Luján Estrada
authors: Francisco José
authors: FJ
authors: Muñoz Barradas
authors: Juan Osvaldo
authors: JO
authors: Talavera Piña
authors: Olga Lidia
authors: OL
authors: Vera Lastra
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D006801:Humans; D008800:Mexico; D060735:Pharmacovigilance; D012216:Rheumatic Diseases / Q000188:drug therapy*
chemical_list: D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals