Abstract
Background
Biosimilars have been available in the European Union since 2006. However, their uptake in routine care is heterogeneous across countries.
Aims
To compare the safety information of biosimilars and their originators based on the information in the EU risk management plan (RMP).
Methods
A cross-sectional analysis on publicly available regulatory documents (RMPs and Summaries of Product Characteristics) of biosimilars and corresponding originators until 1 November 2015 was performed. The safety concerns were extracted and merged into General Safety Concerns and clinical relevancy was assessed. The frequency of safety concerns and the representation of these safety concerns per general safety concern were assessed either comparing RMPs of biosimilars and originators (if available for both) or comparing RMPs with the Summary of Product Characteristics of the originator.
Results
Nineteen biosimilars and 6 originators were included. Overall, 55 general safety concerns (12 low, 21 medium and 22 highly clinically relevant) were identified. For all active substances, except for infliximab, no or only one difference was found in the listed general safety concerns. Comparison of regulatory documents for infliximab identified 3 medium clinically relevant general safety concerns more for infliximab biosimilars and 2 general safety concerns more for its originator.
Conclusion
Based on publicly available information filed for regulatory purposes, no substantial differences were observed in the reporting of safety information for biosimilars and related originators. A direct comparison between biosimilars and related originators through formal post-marketing studies is needed to evaluate specific safety issues emerging during the products' life cycle.
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