Product traceability of US adverse event reports in Med-Watch for multisource biologics prior to introduction of biosimilars

4^th International Conference and Exhibition on Biologics & Biosimilars

October 26-28, 2015 Baltimore, USA

Stella Stergiopoulos

Tufts University, USA

Posters-Accepted Abstracts: J Bioanal Biomed

Abstract :

Biologics differ from small molecule drugs in that the structure of the active ingredient in addition to the entire compound can vary with changes in manufacturing procedures. The possibility that these differences in structure could result in variable adverse events (AEs) increases the need for accurate and complete adverse event reports including unique brand name, lot number and manufacturer identification. The introduction of biosimilars into the US market may create an even stronger demand for improved pharmacovigilance to ensure proper attribution of AEs. To explore the traceability of biologics in the FDA�s current adverse event reporting system (FAERS), all primary suspect US reports from Q4 2005 � Q3 2013 for two classes of multi-sourced biologics, Insulin and Human Growth Hormone (HGH), were analyzed. The rate of identifiable names was 92% for HGH drugs and 84% for insulin drugs. Lot number completion rates were lower, with a higher prevalence for insulin drugs (32%) than for HGH drugs (13%). Additional trends, such as NDA number as an identifier, and accuracy of reports by reporter, were identified. Results suggest that recognizable brand names can result in high name attribution. However, significant number of reports can go unattributed even with no biosimilar on market. Additionally, lot number completions were low. These findings highlight the need for improving how AEs are reported to FAERS, such as increased education and system improvements to encourage use of identifiable names and lot numbers for proper drug attributably, especially as biosimilars are introduced into the US.

Biography :

Email: Stella.Stergiopoulos@tufts.edu