Safety and efficacy comparisons of rituximab biosimilars to the reference product in patients with cancer: a systematic meta-analysis review

Abstract

Aim

To compare the efficacy and safety of rituximab biosimilars to reference rituximab in patients with cancer.

Data Sources

A systematic review and meta-analysis was conducted in accordance with PRISMA guidelines. MEDLINE, EMBASE, and Cochrane Central databases were searched from inception to 12 January 2022 to obtain all randomised control trial (RCTs) reporting on the safety and efficacy outcomes of patients with cancer treated with rituximab biosimilars.

Study Selection

All RCTs comparing the reference rituximab with a biosimilar, conducted in inpatient and outpatient settings, were included in the systematic review.

Results

Twenty-nine RCTs were identified to report on patients treated with rituximab. The odds of achieving overall response rate in patients treated with a rituximab biosimilar compared to the reference over at least 24 weeks of treatment was 1.06 (95% confidence interval [CI] 0.88–1.26). The proportion of patients experiencing any treatment emergent adverse events were comparable between the two study arms (OR 1.20 [95% CI 0.98–1.49]).

Conclusion

Biosimilars for rituximab have comparable efficacy and safety profiles in treatment naïve patients; however, evidence for efficacy and safety of switching patients from reference biologic to biosimilar is lacking, and further research is required.