Real-world analysis of treatment patterns for NHL and CLL in Germany reveals high acceptance of rituximab biosimilar use during first 24 months post-approval

Since the approval of two rituximab biosimilars in 2017, use of these medicines in patients with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukaemia (CLL) has increased sevenfold in Germany – suggesting advanced familiarity among physicians may lessen conservative attitudes to their clinical application.

Rituximab was the first approved therapeutic monoclonal antibody in oncology and is still a fundamental component of treatment for NHL and CLL. Based on totality of evidence from a comprehensive comparability exercise, including analytical, preclinical, and clinical testing versus reference medicine, two rituximab biosimilars, Rixathon® and Truxima®, were approved by the EMA in 2017. Since real-world evidence collected during routine clinical practice in varied patient populations can usefully complement clinical trials data, this study used data from electronic health records and analysed treatment patterns with rituximab biosimilars in NHL and CLL patients in office-based care centres in Germany.

Findings

A total of 38 different rituximab-containing therapeutic protocols were used in 1,241 patients. In over 7,500 total rituximab cycles, a rituximab biosimilar was used in just over half (55%). A trend for increasing use of biosimilar over reference rituximab was noted over time. Between July 2017 and June 2019, use of biosimilar rituximab rose from 12% to 83% while that for reference rituximab slipped from 53% to 16% for both NHL and CLL. Among 70 patients who switched rituximab medicines during the observation period: approximately 50% switched from reference to biosimilar, 20% between biosimilars, and less than 30% from biosimilar to reference rituximab.

Although reasons for the selection of rituximab reference or biosimilar product were not recorded, it could be surmised that prospect of cost savings was primary motivation. Indeed, given the high cost of reference rituximab, use of its lower-priced biosimilar version could allow significant savings that might be reinvested in other aspects of healthcare. Uptake of biosimilar rituximab is increasing, likely fuelled by greater acceptance of these medicines by the oncology community combined with economic benefits.

Key takeaway

Real-world evidence collected during routine clinical practice may be used to complement clinical trials data. Analysis of treatment patterns over two years from office-based care centres showed an increasing trend for use of biosimilars over originators.