EBE and ESCHER launched new project ‘Pharmacovigilance of biologics’
Escher, the TI Pharma platform for regulatory innovation, launched a new project,‘Pharmacovigilance of biologics’ in November 2014. It will address the challenges of product and batch traceability in adverse drug reaction reporting.
‘Biologic’ products are medicinal products obtained from natural sources such as humans, animals or micro-organisms. They are much larger and more complex than small molecule medicines, and more difficult to manufacture. Biologics can sometimes be more sensitive to small alterations in the manufacturing process, which can influence product characteristics and result in batch-to-batch variations. EU pharmacovigilance legislation specifically calls out the need to report adverse drug reactions (ADRs) for these products by brand name and batch number to ensure that ADRs are accurately ascribed to the correct causative product. However, a study has found that only about 21% of ADR reports for biologics contained the batch numbers.
Working within community and hospital settings, the new project’s objectives are to evaluate practices and health information systems for tracking biologic product administration and the ADR reporting in the EU . It will also be estimating the potential impact of misclassification of products during ADR reporting on safety signals for biologics. The project is executed in collaboration with Utrecht University and Exon Consultancy. For the investigation of the practices in the Netherlands Escherwill collaborate intensively with the Royal Dutch Pharmacists Association and with the Netherlands Pharmacovigilance Centre Lareb. The project is supported by an unrestricted research grant of the European Biopharmaceutical Enterprises (EBE).