Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions

Abstract

Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? A high level of commercial name identifiability on all reports of adverse drug reactions (ADRs) is important to ensure timely and effective discrimination of products. The increased availability of biosimilars in Europe and potential changes in reporting practices over time might influence identifiability. It is, therefore, important to regularly monitor the level of identifiability. WHAT QUESTION DID THIS STUDY ADDRESS? We investigated the product identifiability in ADR reports received from European clinical practices between 2011 and 2019 for biological products for which biosimilars are approved. WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? We show identifiability to be, on average, 91.5%.Identifiability decreased over time. This decrease was mainly driven by five products mostly used in oncology. Availability of biosimilars does not seem to negatively impact identifiability. HOW MIGHT THIS CHANGE CLINICAL PHARMA-COLOGY OR TRANSLATIONAL SCIENCE? The high level of identifiability is reassuring, supporting the timely identification of product specific safety signal. The downward trend on identifiability over time needs attention and improvement for all biologicals.

A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies

“…These deviating or missing results did not preclude approval, as similarity was shown for the relevant QAs and in dedicated PK studies and confirmed by clinical data in the efficacy study. As this paper analysed already approved biosimilar products, and subsequent experience with these products to date has not resulted in any safety or efficacy issues following their approval, 16,55,56 it can be concluded that the regulatory decisions taken were correct.…”

“…Furthermore, the EU pharmacovigilance systems and risk management planning are sufficiently robust 16,55,56 to detect safety signals in postmarketing use. However, safety signals (including reports on reduced efficacy) are not anticipated, because more than a decade of clinical experience indicates that a new safety signal solely identified with a biosimilar is extremely unlikely 55,56 …”

“…However, safety signals (including reports on reduced efficacy) are not anticipated, because more than a decade of clinical experience indicates that a new safety signal solely identified with a biosimilar is extremely unlikely. 55,56 For the biosimilars included in this study, differences in several QAs were found. As part of the EMA approval process, applicants were challenged to justify that the observed differences would have no impact on the clinical performance of the biosimilar.…”