Rituximab – the first biosimilar monoclonal antibodies in hematooncology

Abstract

The introduction of biosimilars can increase the availability of effective and life-saving therapies, while reducing their costs. Biosimilar and reference biological drugs are functionally the same molecules, identical in quality, biological activity, safety profile, immunogenicity and therapeutic efficacy. Recently, two pivotal registration studies for rituximab biosimilars have been summarized. In patients with follicular lymphoma (FL), the efficacy and safety of rituximab GP2013 was assessed in ASSIST-FL phase III clinical trial. At median follow-up of 11.6 months, the primary endpoint was achieved, in the GP2013 group overall response was 87% (271/311 patients) and 88% (274 /313 patients) in the reference arm). The incidence of adverse events and severe toxicities was similar in both groups. In the second study of 140 patients with FL, the overall response was 97.0% (64 of the 66 patients) in the CT-P10 group and 92.6% (63 of the 68 patients) in the group treated with rituximab. Treatment-emergent adverse events were reported for 83% (58 of 70 patients) in the CT-P10 treatment group and 80% (56 of 70) in the reference rituximab treatment group. Results of these studies indicate similar activity and toxicity profile of GP2013 and CT-P10 to the original rituximab.