Biosimilars have been available in the European Union since 2006.
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.
Additional Information
Link to Study: http://onlinelibrary.wiley.com/doi/10.1111/bcp.13454/full
About Journal
The British Journal of Clinical Pharmacology (BJCP) contains papers and reports on all aspects of drug action in humans: invited review articles, original papers and correspondence. The journal enjoys a wide readership, bridging the gap between the medical profession, clinical research and the pharmaceutical industry.
Penny Smith
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