As treatment for relapsing-remitting multiple sclerosis, glatiramer acetate generic drug and brand drug had equivalent efficacy, safety, and tolerability, according to a study of 794 patients with relapsing-remitting multiple sclerosis aged 18 to 55 years. Researchers found:
• Estimated mean numbers of gadolinium-enhancing lesions with generic drug and brand drug were lower than with placebo, confirming study sensitivity.
• For gadolinium-enhancing, the estimated ratio of generic drug to brand drug was within the predefined equivalence margin.
• The incidence, spectrum, and severity of reported adverse events, including injection site reactions, were similar in the generic drug and brand drug groups.
Citation: Cohen J, Belova A, Selmaj K, et al. Equivalence of generic glatiramer acetate in multiple sclerosis. [Published online ahead of print October 12, 2015]. JAMA Neurol. doi: 10.1001/jamaneurol.2015.2154.