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Although biosimilars have been available in the European Union for more than ten years, their uptake in routine care across the region has been highly variable.
A cross-sectional analysis was conducted on publicly available information on biosimilars and their originators, filed for regulatory purposes at European Medicines Agency level. A total of 19 biosimilars and 6 originators were included.
Overall, 142 safety concerns were retrieved, corresponding to 55 general safety concerns. Of these, 22 (40%) were classified as highly clinically relevant, with 21 (38%) as medium and 12 (22%) as low clinical relevance.
For all substances, except infliximab, no, or only one, difference was found in the safety concerns reported for biosimilars and their originators. For infliximab, a single difference was considered a highly clinically relevant safety issue.
Direct comparison between biosimilars and related originators through formal post-marketing studies remains important to evaluate specific safety and effectiveness issues, the researchers concluded in the British Journal of Clinical Pharmacology (online, 22 November 2017)[1]
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References
[1] Lepelaars L, Renda F, Pani L et al. Comparing safety information of biosimilars with their originators: a cross-sectional analysis of European Risk Management Plans. Br J Clin Pharmacol 2017. doi: 10.1111/bcp.13454
