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

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• 作者：Rolando Espinosa Morales^a ; ^{rolespi@yahoo.com} ; Alejandro Dí ; az Borjó ; n^b ; Leonor Adriana Barile Fabris^c ; Jorge Antonio Esquivel Valerio^d ; Gabriel Medrano Ramí ; rez^e ; Cé ; sar Alejandro Arce Salinas^f ; Eduardo Rubé ; n Barreira Mercado^g ; Mario Humberto Cardiel Rí ; os^h ; Efraí ; n Dí ; az Jouanenⁱ ; Francisco Javier Flores Murrieta^j ; Antonio Fraga Mouret^k ; Mario Alberto Garza Elizondo^l ; Miguel Luj&aacute ; n Estrada^m ; Francisco José ; Muñ ; oz Barradasⁿ ; Juan Osvaldo Talavera Piñ ; a^o ; Olga Lidia Vera Lastra^p
• 关键词：Biosimilar ; Biocomparable ; Rheumatoid arthritis ; Biologic ; Biotechnological ; Innovator drugs
• 刊名：Reumatolog¡§aa Cl¡§anica (English Edition)
• 出版年：2013
• 出版时间：March-April, 2013
• 年：2013
• 卷：9
• 期：2
• 页码：113-116
• 全文大小：211 K

文摘

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.