Experimental evaluation of bioequivalenceт of the original and generic peptide drugs in multiple sclerosis

Multiple sclerosis is a chronic, widespread neurodegenerative disease, which is accompanied by a considerable degree of disability and requires lifelong drug therapy. In this regard, the relevant objective for the production of generic drugs for treating multiple sclerosis, so-called generics, is to ensure their quality to be at the level of the original forms. This article provides an overview of methods for determining the comparability of generics and original drugs for major groups of medications used in the treatment of multiple sclerosis: glatiramer acetate preparations, mitoxantrone, monoclonal antibodies, immunomodulating agents, and preparations based on interferon-β. Experimental allergic encephalomyelitis, a standard model for verifying specific activity of glatiramer acetate preparations, was used as an example to analyze factors that impair the consistent assessment of generics. Approaches to standardization of methods for monitoring the effectiveness of medications of this group were suggested.