Comparing safety information of biosimilars with their originators: a cross-sectional analysis of European risk management plans
| Autor: | Giuseppe Pimpinella, Leroy R. A. Lepelaars, Luca Pani, Francesco Trotta, Aukje K. Mantel-Teeuwisse, Hubert G. M. Leufkens, Gianluca Trifirò, Giovanni Tafuri, Francesca Renda |
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| Rok vydání: | 2018 |
| Předmět: |
Pharmacology
Risk management plan Actuarial science Cross-sectional study business.industry Biosimilar Product characteristics 03 medical and health sciences 0302 clinical medicine 030220 oncology & carcinogenesis media_common.cataloged_instance Pharmacology (medical) 030212 general & internal medicine Business Summary of Product Characteristics European union Routine care Risk management media_common |
| Zdroj: | British Journal of Clinical Pharmacology. 84:738-763 |
| ISSN: | 0306-5251 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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