Although biosimilars were approved in the EU more than a decade ago, uptake is variable across countries as clinicians are reticent to prescribe biosimilars to new patients as well as substitute biosimilars for originator drugs in patients already successfully treated. Similar behavior has been observed in the United States.
This reluctance is likely related to the fact that biologics production is much more complicated than small molecule production, and it can be hard to produce identical batches of drugs. However, it has been found that lot-to-lot variations do not necessarily translate to clinically relevant differences among batches.
A cross-sectional analysis of safety information found in the EU risk management plan by researchers from Italy and the Netherlands sought to confirm that biosimilars were as safe as their originators.
In the paper published today in British Journal of Clinical Pharmacology, the team compared the safety information of biosimilars and their originators. Nineteen biosimilars and 6 originators were included in the study. Fifty-five general safety concerns (12 low, 21 medium and 22 highly clinically relevant) were identified. Some differences were found between infliximab biosimilars and their originator, but only one was considered a highly clinically relevant issue.
The researchers conclude that based on the publicly available information filed for regulatory purposes, no substantial differences were observed in the reporting of safety information for biosimilars and related originators.
They recommend a direct comparison between biosimilars and related originators post-marketing to evaluate specific safety issues emerging during the products’ life cycle.