New Analysis Provides Reassurance on Biosimilar Safety


And they’re … safe.

Biosimilars, which have been available in the European Union since 2006, show no substantial differences in the reporting of safety information than their originators, according to a new analysis in the British Journal of Clinical Pharmacology.

The analysis included 19 biosimilars and six 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 three medium clinically relevant general safety concerns more for infliximab biosimilars and two general safety concerns more for its originator.

“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,” the study authors report. “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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