P05: A Review of Problems with Pharmacovigilance Programs and Biologics
Poster Presenter
Philip James Schneider
Chair, Advisory Board
Alliance for Safe Biologic Medicines United States
Objectives
Good pharmacovigilance programs are critical to creating confidence among clinicians in biosimilars, which are approved for use based more on analytic studies rather than clinical trials
Method
A literature review of studies of pharmacovigilance programs was conducted and data from EudraVigilance - European database of suspected adverse drug reaction reports were reviewed
Results
In a study of Canadian physicians who prescribe biologics, 20% record only the product’s nonproprietary
name not the brand name in the patient medical record. When reporting adverse events,
only 70% use the brand name and 26% record only the product’s non-proprietary name. Only 23% consistently include the batch number and 20% never include it. EU Adverse Event Reports reflect these survey findings. 24.88% of EU adverse event reports for infliximab in 2018 did not specify brand name despite the fact that
reporting by brand name has been required by law since 2012. In the UK, ADR reports submitted to the Yellow Card Scheme for biologics, 38% had an identifiable brand name and 15% had a batch number included. The authors that brand name and batch number traceability for biologics in the UK is low. In a WHO report titled "Regulatory challenges with biosimilars: an update from 20 countries, it notes the lack of consistency in the nomenclature of biologics and biosimilars that causes concern about "prescription mix-ups, unintended switching and traceability." The authors state: "...it is clear that naming and labeling are both very important for the identification of products and also for pharmacovigilance and prescribing."
Conclusion
Adverse drug event reports are often incomplete, missing information about the exact identity of the drug whose reaction is being reported. Because biosimilars are not exact copies of the reference molecule, it is important to distinguish among the different biologics; reference products and biosimilars. Brand name and lot numbers are good ways to do this, but these are not always used in reports or the clinical record. Having distinguishable non-proprietary names for reference products and biosimilars would create another layer of safety in identifying the medicine the patient received. Clinical experience gathered from the increasing use of biologics and biosimilars is more important given the declining role of clinical studies needed for biosimilar approval. This experience will enhance prescriber and patient confidence in biosimilar, speed the adoption of these less expensive medicines, reduce health care costs, and increase access to these important treatments.
