The beginning of the new era of monoclonal antibodies biosimilars use in oncology:current international guidelines and the results of clinical trial of the first Russian rituximab biosimilar in patients with B-cell non-Hodgkin’s lymphoma

Abstract

This article contains the detailed analysis of current approach to non-clinical and clinical development of monoclonal antibody biosimilars which is described in current guidelines of the European Medicines Agency (2012). Requirements of European regulatory authorities regarding evidence, which allows to demonstrate absence or presence of significant differences between biosimilar and original medicinal product are also discussed. There is the first publication of data from international clinical study of the 1st Russian rituximab biosimilar in patients with B-cell non-Hodgkin's lymphoma, which showed no differences with the reference medicinal product MabThera® in terms of efficacy and safety.

Keywords

• cd20
• biosimilars
• monoclonal antibodies
• rituximab
• b-cell non-hodgkin’s lymphoma
• cd20