Posted by Michael Wonder on 28 Nov 2017
Comparing safety information of biosimilars with their originators: a cross-sectional analysis of European Risk Management Plans
22 November 2017 - Biosimilars have been available in the European Union since 2006. However, their uptake in routine care is heterogeneous across countries.
A cross-sectional analysis on publicly available regulatory documents (RMPs and Summaries of Product Characteristics) of biosimilars and corresponding originators until 1 November 2015 was performed. The safety concerns were extracted and merged into General Safety Concerns and clinical relevancy was assessed. The frequency of safety concerns and the representation of these safety concerns per general safety concern were assessed either comparing RMPs of biosimilars and originators (if available for both) or comparing RMPs with the Summary of Product Characteristics of the 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. 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.
