title: How to compare biologic drugs.
abstract: This consensus document reviews the evidence on the evaluation of biological drugs. The main conclusions of the group are: a) the current evidence on biological comparisons is based on indirect comparisons and is generally unreliable and with important methodological limitations. Therefore, b) it is considered necessary to amend the regulatory directives in the sense of strongly favoring randomized non-inferiority studies comparing face to face the new biological treatment with current standards, avoiding trials versus placebo, c) A key element in this process will be determined by consensus among regulatory agencies, scientific societies, the pharmaceutical industry and health authorities regarding the clinical differences that should be considered relevant in each of the conditions tested.
authors.affiliation: Servicio de Aparato Digestivo, Corporació Sanitària Universitària Parc Taulí, Universitat Autònoma de Barcelona, Sabadell, España; CIBERehd, Madrid, España. Electronic address: xcalvet@tauli.cat.
authors.forename: Xavier
authors.initials: X
authors.lastname: Calvet
authors.affiliation: CIBERehd, Madrid, España; Departamento de Farmacología, Facultad de Medicina, Universidad de Valencia, Valencia, España; Farmacología Clínica, Hospital Universitario Doctor Peset, Valencia, España.
authors.forename: Juan Vicente
authors.initials: JV
authors.lastname: Esplugues
mesh_terms: D001688:Biological Products; D057186:Comparative Effectiveness Research / Q000941:ethics / Q000379:methods*; D004345:Drug Industry; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods*
chemical_list: D001688:Biological Products
keywords: Biologic drugs; Comparaciones indirectas; Estudios de no inferioridad; Fármacos biológicos; Indirect comparisons; Non inferiority studies