2013: Mexican College of Rheumatology; CAArce Salinas; LABarile Fabris; ERBarreira Mercado; MHCardiel Ríos; ADíaz Borjón; EDíaz Jouanen; REspinosa Morales; JAEsquivel Valerio; FJFlores Murrieta; AFraga Mouret; MAGarza Elizondo; MLuján Estrada; GMedrano Ramirez; FJMuñoz Barradas; JOTalavera Piña; OLVera Lastra;
NLM PMID: 23395225
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.
Title and Abstract from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Data mined from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Last MEDLINE®/PubMed® update: 1st of December 2015