TY - JOUR
T1 - Comparing safety information of biosimilars with their originators
T2 - A cross-sectional analysis of European risk management plans
AU - Lepelaars, Leroy R.A.
AU - Renda, Francesca
AU - Pani, Luca
AU - Pimpinella, Giuseppe
AU - Leufkens, Hubert G.M.
AU - Trifirò, Gianluca
AU - Tafuri, Giovanni
AU - Mantel-Teeuwisse, Aukje K.
AU - Trotta, Francesco
PY - 2018/4
Y1 - 2018/4
N2 - Background and aims: Biosimilars have been available in the European Union (EU) since 2006. However, their uptake in routine care is heterogeneous across countries. The aim of the present study was to compare the safety information of biosimilars and their originators based on the information in the European risk management plan (RMP). Methods: A cross-sectional analysis on publicly available regulatory documents (RMPs and Summaries of Product Characteristics) of biosimilars and corresponding originators up to 1 November 2015 was performed. The safety concerns were extracted and merged into general safety concerns, and clinical relevance was assessed. The frequency of safety concerns and the representation of these safety concerns per general safety concern were assessed by either comparing RMPs of biosimilars and originators (if available for both) or comparing RMPs with the Summary of Product Characteristics of the originator. Results: Nineteen biosimilars and six originators were included. Overall, 55 general safety concerns (12 low, 21 medium and 22 highly clinically relevant) were identified. For all active substances, except for infliximab, no or only one difference was found in the listed general safety concerns. Comparison of regulatory documents for infliximab identified three medium clinically relevant general safety concerns more for infliximab biosimilars and two general safety concerns more for its originator. Conclusion: 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 postmarketing studies is needed to evaluate specific safety issues emerging during the products' life cycle.
AB - Background and aims: Biosimilars have been available in the European Union (EU) since 2006. However, their uptake in routine care is heterogeneous across countries. The aim of the present study was to compare the safety information of biosimilars and their originators based on the information in the European risk management plan (RMP). Methods: A cross-sectional analysis on publicly available regulatory documents (RMPs and Summaries of Product Characteristics) of biosimilars and corresponding originators up to 1 November 2015 was performed. The safety concerns were extracted and merged into general safety concerns, and clinical relevance was assessed. The frequency of safety concerns and the representation of these safety concerns per general safety concern were assessed by either comparing RMPs of biosimilars and originators (if available for both) or comparing RMPs with the Summary of Product Characteristics of the originator. Results: Nineteen biosimilars and six originators were included. Overall, 55 general safety concerns (12 low, 21 medium and 22 highly clinically relevant) were identified. For all active substances, except for infliximab, no or only one difference was found in the listed general safety concerns. Comparison of regulatory documents for infliximab identified three medium clinically relevant general safety concerns more for infliximab biosimilars and two general safety concerns more for its originator. Conclusion: 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 postmarketing studies is needed to evaluate specific safety issues emerging during the products' life cycle.
KW - Biosimilar
KW - EMA
KW - Regulatory
KW - Risk management plan
KW - Safety profile
UR - http://www.scopus.com/inward/record.url?scp=85040710998&partnerID=8YFLogxK
U2 - 10.1111/bcp.13454
DO - 10.1111/bcp.13454
M3 - Article
AN - SCOPUS:85040710998
SN - 0306-5251
VL - 84
SP - 738
EP - 763
JO - British Journal of Clinical Pharmacology
JF - British Journal of Clinical Pharmacology
IS - 4
ER -