Current State of Biosimilars in Mexico: The Position of the Mexican College of Rheumatology, 2016

Publication date: May–June 2018Source: Reumatología Clínica (English Edition), Volume 14, Issue 3Author(s): Daniel Xibille, Sandra Carrillo, Gabriela Huerta-Sil, Ramiro Hernández, Leonardo Limón, Guadalupe Olvera-Soto, Luis Javier Jara-Quezada, Abdieel Esquivel, Marcela Pérez-RodríguezAbstractThe present document is a position statement of the Mexican College of Rheumatology on the use of biosimilars in rheumatic diseases. This position considers that biosimilars should be considered as interchangeable, that automatic substitution without previous notice in stable patients during follow-up is not ethical, that the approval of a biosimilar should only be given after exhaustive review of preclinical and clinical data marked by Mexican regulations, that it should be clearly stated in the nomenclature of biologic drugs which is the innovator and which is the biosimilar, that it is not correct to choose a biosimilar as treatment based only on economic reasons or extrapolate indications based only on the approval of the innovator and in the absence of safety and efficacy data for the biosimilar.ResumenEl presente documento refleja el posicionamiento del Colegio Mexicano de Reumatología y de expertos sobre el uso de medicamentos biocomparables (conocidos como biosimilares en otros países) en enfermedades reumáticas. En resumen, este posicionamiento considera que si bien los biocomparables deben considerarse como intercambiables, no es ética la sustitución automática de...
Source: Reumatologia Clinica - Category: Rheumatology Source Type: research