Leroy R A Lepelaars1, Francesca Renda2, Luca Pani2, Giuseppe Pimpinella2, Hubert G M Leufkens1,3, Gianluca Trifirò4, Giovanni Tafuri2, Aukje K Mantel-Teeuwisse1, Francesco Trotta2,5. 1. WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands. 2. Italian Medicines Agency (AIFA), Rome, Italy. 3. Medicines Evaluation Board (CBG-MEB), Utrecht, the Netherlands. 4. Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy. 5. Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Abstract
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.
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.
Authors: Hans C Ebbers; Aukje K Mantel-Teeuwisse; Ellen H M Moors; Huub Schellekens; Hubert G Leufkens Journal: Drug Saf Date: 2011-04-01 Impact factor: 5.606
Authors: Ciara C O'Sullivan; Ian Bradbury; Christine Campbell; Marc Spielmann; Edith A Perez; Heikki Joensuu; Joseph P Costantino; Suzette Delaloge; Priya Rastogi; Dimitrios Zardavas; Karla V Ballman; Eileen Holmes; Evandro de Azambuja; Martine Piccart-Gebhart; Jo Anne Zujewski; Richard D Gelber Journal: J Clin Oncol Date: 2015-06-22 Impact factor: 44.544
Authors: Leroy R A Lepelaars; Francesca Renda; Luca Pani; Giuseppe Pimpinella; Hubert G M Leufkens; Gianluca Trifirò; Giovanni Tafuri; Aukje K Mantel-Teeuwisse; Francesco Trotta Journal: Br J Clin Pharmacol Date: 2018-01-18 Impact factor: 4.335
Authors: Stanley B Cohen; Sebastiao C Radominski; Hideto Kameda; Alan J Kivitz; Michael Tee; Carol Cronenberger; Min Zhang; Sarah Hackley; Muhammad I Rehman; Oliver von Richter; Rieke Alten Journal: BioDrugs Date: 2020-04 Impact factor: 5.807