Non-biological complex drugs and their analogues in the pathogenetic therapy of multiple sclerosis: Issues of efficacy and safety in clinical use

Abstract

The paper generalizes the experience with one of the main original drugs for the treatment of multiple sclerosis (MS) – glatiramer acetate (GA, Copaxone®, Teva) in large Russian MS centers. The performed analysis of clinical trials suggests the high efficacy and favorable safety profile of the drug. The fact that patents for a number of effective and widely used original drugs, including those for agents from a group of immunomodulators, used to treat MS expire is one of the features of the current development of medicine. Due to the fact that most of them belong to interferons-β, i.e. biologicals, or structurally close to nonbiological complex drugs, the authors discuss the need to conduct comparative clinical trials of the original drug and follow-on glatiramoids with measured endpoints that can be used to establish their efficacy, safety, and evidence for therapeutic equivalence in order to examine their potential interchangeability.

Keywords

• multiple sclerosis
• glatiramer acetate
• clinical trial
• biological analogues