Therapeutic applications of biosimilar monoclonal antibodies: Systematic review of the efficacy, safety, and immunogenicity in autoimmune disorders.

Abstract Purpose Biosimilars are biological products that could be used instead of reference biological drugs to provide a less costly option for treating patients with autoimmune disorders. With the introduction of biosimilar monoclonal antibodies into the drug market, the main concern is confirming the similarity in terms of efficacy, safety, and immunogenicity of these biosimilars with their reference products. The presence of valuable comparative clinical trials to demonstrate these similarities with analytical methods is challenging. This review discusses the similarity between biosimilar mAbs and reference products as candidates for autoimmune diseases. Methods Data on efficacy endpoints, adverse events, production of anti-drug antibodies (ADAs), and neutralizing antibodies (nAbs) were collected from trials. Findings Overall, these data suggest the similarity between biosimilar mAbs and reference products in terms of safety and efficacy. Implications Biosimilars are used in a wider range of diseases, and by examining their similarities in all those diseases with reference drugs, more comprehensive results can be obtained.