Pharmacovigilance of biologics

Biologics are medicinal products obtained from natural sources such as humans, animals or micro-organisms. Biologics are much larger and more complex than small molecule medicines, as well as that they are 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. The 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, recent studies have found that only about 20% of ADR reports for biologics contained the batch numbers.

Working within community and hospital settings, the objectives of this new project are to evaluate practices and health information systems for tracking biological product information and the ADR reporting processes in the EU with a case study in the Netherlands. This project 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, Escher is collaborating with the Royal Dutch Pharmacists Association, the Dutch Association of Hospital Pharmacists and the Netherlands Pharmacovigilance Centre Lareb. The project is supported by an unrestricted research grant of the European Biopharmaceutical Enterprises (EBE).

Results:

• Klein K, Scholl JH, Vermeer NS, Broekmans AW, Van Puijenbroek EP, De Bruin ML, Stolk P. Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports. Drug Saf 2016;39:185-92. doi: 10.1007/s40264-015-0383-8.
• Klein K, De Bruin ML, Broekmans AW, Stolk P. Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers. BioDrugs 2015;29:373–9. doi:10.1007/s40259-015-0149-y
• Vermeer NS, Ebbers HC, Straus SM, Leufkens HG, Egberts TC, De Bruin ML. The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product specific risks for biologicals: a simulation study. Pharmacoepidemiol Drug Saf 2015 Dec 16. doi: 10.1002/pds.3929
• Pharmacovigilance of Biologics: Workshop summary – 20th of May 2015, Amsterdam, The Netherlands