Eduardo 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 patients each. Patients from the first group were treated with Avonex®, 30 mg-per-week. Patients from the second group were treated with Axuareb® at the same dose. All patients were followed for a period of 24 months. Forty-five patients (90%) out of the initially recruited 50 patients completed the follow-up period. Annual relapse rates were 11% and 8% for Avonex and Axuareb, respectively. The proportions of relapse-free, improvement and detriment showed non-significant differences (p>0.05) between groups. The incidence of side effects showed a non-significant difference (p>0.05) between groups. SF-36 data of physical and mental status demonstrated non-significant differences between groups after the follow-up period. Although, MRI findings demonstrated a significant increase (p<0.05) in the number of demyelinating lesions after the follow-up period in both groups of patients, the group of patients treated with Axuareb demonstrated a significantly reduced mean number of lesions after the follow-up period. In conclusion, both drugs showed similar effectiveness and safety. Thus, from the results of this clinical trial, it seems that Axuareb, a biosimilar IFN is a safe and reliable alternative for treating patients with MS.