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World J Gastroenterol ; 23(2): 197-203, 2017 Jan 14.
Artigo em Inglês | MEDLINE | ID: mdl-28127193

RESUMO

Biologic compounds are obtained from living organisms or cell cultures by means of biotechnology methods. A similar biologic drug, commonly called biosimilar, is a product copied by a native approved biologic drug whose license has expired. Biosimilar drugs usually are marketed at a lower price and provide important financial savings for public healthcare systems. Some differences between biosimilars and original biologic drugs might exist but they are acceptable if they fall within defined "boundaries of tolerance": differences in some features between the two molecules are considered important only if clinical relevant. Considering that the efficacy of the innovator biologic drug has already been established, the clinical studies required for approval of a biosimilar could be reduced compared with those required for the approval of the originator. In this review, real life data available in inflammatory bowel disease patients treated with biosimilars are reported, documenting in general satisfactory outcomes, sustained efficacy and no sign of increased immunogenicity, although, further controlled data are awaited.


Assuntos
Adalimumab/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infliximab/uso terapêutico , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Adulto , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais/efeitos adversos , Terapia Biológica/métodos , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/efeitos adversos , Criança , Aprovação de Drogas , Humanos , Infliximab/administração & dosagem , Infliximab/efeitos adversos , Vigilância de Produtos Comercializados , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
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