R. Meixueiro-Montes de Oca
Mexico
Research Article
A Therapeutic Trial of Bioequivalence Between Two Interferons Beta – 1a for Treating Relapsing – Remitting Multiple Sclerosis
Author(s): Eduardo Perusquía-Ortega, Arturo Violante-Villanueva, R. Flores-Hernandez, R. Meixueiro-Montes de Oca, Pablo Antonio Ysunza, Roger Carrillo G and Pacheco-AispuroEduardo Perusquía-Ortega, Arturo Violante-Villanueva, R. Flores-Hernandez, R. Meixueiro-Montes de Oca, Pablo Antonio Ysunza, Roger Carrillo G and Pacheco-Aispuro
In order to appropriately support the equivalence between a biosimilar and the referenced biopharmaceutical it is essential to carry out equivalence or non-inferiority clinical studies. The objective of this paper was to study the therapeutic bioequivalence of IFN β-1A biosimilar vs. IFN β-1A innovator. The efficacy and safety of these drugs was assessed in Mexican patients under treatment for relapsing-remitting multiple sclerosis (RRMS). A parallel, multicenter, prospective and comparative study was carried out. Fifty patients with confirmed RRMS were studied. The following parameters were considered for the diagnosis of confirmed RRMS: Magnetic Resonance Imaging (MRI) demonstrating demyelinating lesions; expanded disability status scale (EDSS) scores between 0 – 5.5; and McDonald’s criteria compatible with MS. Patients were randomly divided into 2 groups of 25.. Read More»
