Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases

Drug Saf. 2013 Aug;36(8):617-25. doi: 10.1007/s40264-013-0073-3.


Background: Adverse drug reactions (ADRs) of biopharmaceuticals can be batch or product specific, resulting from small differences in the manufacturing process. Detailed exposure information should be readily available in systems for postmarketing safety surveillance of biopharmaceuticals, including spontaneous reporting systems (SRSs), in which reports of ADRs are collected.

Objective: The aim of this study was to explore the current status of traceability of biopharmaceuticals in the US and the EU up to patient level in SRSs.

Design and setting: A cross-sectional study was conducted over the period 2004-2010, including ADR reports from two major SRSs: the FDA Adverse Event Reporting System (FAERS) in the US and EudraVigilance (EV) in the EU.

Main outcome measures: The availability of batch numbers was determined for biopharmaceuticals, and compared with small molecule drugs. For biopharmaceuticals for which a biosimilar has been approved for marketing in the EU, the identifiability of the product (i.e. the possibility of distinguishing the biosimilar from the reference biopharmaceutical) was determined.

Results: A total of 2,028,600 unique ADR reports were identified in the FAERS, reporting a total of 591,380 biopharmaceuticals (of which 487,065 were suspected). In EV there were 2,108,742 unique ADR reports, reporting a total of 439,971 biopharmaceuticals (356,293 suspected). Overall, for 24.0 % of the suspected biopharmaceuticals in the FAERS and 7.4 % of the suspected small molecule drugs (p < 0.001) batch numbers were available. A similar pattern was seen in EV: for 21.1 % of the suspected biopharmaceuticals batch numbers were available, compared with only 3.6 % of the small molecule drugs (p < 0.001). In both SRSs, consumers were most likely to report a batch number for suspected biologicals (36.3 % in the FAERS and 40.7 % in EV). A total of 13,790 biopharmaceuticals (9,759 suspected) for which a biosimilar has been approved in the EU were identified in EV. For 90.4 % of these biopharmaceuticals and 96.2 % of the suspected biopharmaceuticals the product was clearly identifiable.

Conclusion: This study underlines the need for improving traceability of biopharmaceuticals, in particular with respect to individual batches, allowing better identification and monitoring of postmarketing safety issues related to biopharmaceuticals.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adverse Drug Reaction Reporting Systems* / statistics & numerical data
  • Biological Factors / adverse effects*
  • Cross-Sectional Studies
  • Databases, Pharmaceutical*
  • Drug Labeling / statistics & numerical data*
  • Europe
  • Humans
  • Prescription Drugs / adverse effects
  • United States
  • United States Food and Drug Administration


  • Biological Factors
  • Prescription Drugs