Few differences observed in safety information for biosimilars and related originators

A cross-sectional analysis of the safety concerns of biosimilars, compared with their originator products, shows very similar results.

Identical vials

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]


[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

Last updated
Clinical Pharmacist, CP, February 2018, Vol 10, No 2;10(2):DOI:10.1211/PJ.2018.20204187

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