OBJECTIVES: Biosimilars safety concerns are the main obstacle to be faced when interchanging patients from a reference biologic to a biosimilar or from a biosimilar to another. Scattered clinical trials have addressed this issue with mixed results. Thus, the purpose of this systematic review and meta-analysis is to investigate the safety of interchanging from reference biologic to its biosimilar.

RESULTS: A total of 493 journal articles and 17 abstracts were identified in this review. Of these, 10 trials were considered relevant and included in this analysis involving 1,101 participants in the reference–reference group and 1,024 participants in the reference–biosimilar group. The total adverse events, serious adverse events and emergent adverse events were not significantly different between the reference-reference, and reference-biologic arms, relative risk (RR) =0.97 (95% confidence interval [CI], 0.85-1.11), RR=1.04 (95% CI, 0.62-1.73), RR=1.01 (95% CI, 0.82-1.32), respectively. The heterogeneity was generally low to moderate for all study outcomes, except for the TAE (I²=69%). The results did not differ by subgroup analysis using the type of data, disease type, and the reference product.

CONCLUSIONS: Given the similar safety profile when switching between reference to reference or reference to a biosimilar, the use of any of these modalities appears to be acceptable. However, the current data is limited by the number of trials included, and the type of patients/products studied.