Biosimilars have been available in the European Union since 2006. A new British Journal of Clinical Pharmacology analysis of publicly available regulatory documents found no substantial differences in the reporting of safety information for biosimilars and related originators.
The analysis included 19 biosimilars and 6 originators. Overall, 55 general safety concerns (12 low, 21 medium, and 22 highly clinically relevant) were identified. For all 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.
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British Journal of Clinical Pharmacology