Introduction: HLX01 is the first rituximab biosimilar produced in China and the first monoclonal antibody biosimilar marketed in China. The purpose of this study was to comprehensively evaluate whether HLX01 is clinically consistent with the original drug based on real-world data to provide evidence for the clinical substitution of biosimilars in China.
Methods: A single-center retrospective study was conducted to select patients with diffuse large B-cell lymphoma who met the inclusion criteria and were treated with HLX01 or reference rituximab. Baseline characteristics, efficacy and safety results were recorded, and the corresponding statistical analysis was performed for various indicators.
Results: Thirty-three patients diagnosed with diffuse large B-cell lymphoma were included and divided into two groups that received HLX01 or reference rituximab. The results showed no significant difference in the overall response rate (86.7% vs. 88.9%; p = 1.000) or complete response rate (46.7% vs. 55.6%; p = 0.889) between the two groups. Kaplan-Meier survival curves also showed no significant difference in time-to-event variables between the two groups (log-rank = 0.244). Safety was also comparable in both groups.
Conclusions: HLX01 is a suitable replacement for reference rituximab in the treatment of diffuse large B-cell lymphoma and is relatively inexpensive, thereby reducing the economic burden of patients. Nevertheless, the conclusion of this study still needs to be further validated by large-sample real-world data and explored for HLX01 in other indications, such as follicular lymphoma.
Clinical trial registration: Not applicable.
Keywords: HLX01; biosimilar; diffuse large B-cell lymphoma; real-world evidence; rituximab.