The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals.
OBJECTIVE
To describe and assess the outcomes of Periodic Safety Update Report (PSUR) evaluations of biopharmaceuticals.


METHODS
A cross-sectional analysis was performed of follow-up requirements of PSURs submitted for centrally approved biopharmaceuticals in the European Union between 1 July 2008 and 30 June 2010. A follow-up analysis on a subset of products that submitted multiple PSURs within the study period was also performed.


RESULTS
The cross-sectional analysis included 70 PSURs. Potential safety concerns occurred in 57 (83 %) of all PSURs, and 26 (37 %) concluded a need to change the Summary of Product Characteristics (SPC). In comparison to newer products, products authorized for more than 10 years contained significantly fewer potential safety concerns (60 vs. 92 %; p < 0.01) and required fewer SPC changes (15 vs. 46 %; p = 0.03). For 45 products, multiple PSURs were submitted that could be included in a follow-up analysis. For this subset of products, of the 106 newly identified safety potential safety issues, 7 (7%) resulted in requirements for label changes in the following PSUR.


CONCLUSIONS
PSURs facilitate communication between regulators and marketing authorization holders. Potential safety concerns occur for the majority of biopharmaceuticals and throughout their lifecycle, but for established products PSUR evaluations rarely lead to regulatory actions.
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Utrecht University, P.O. Box 80 082, 3508 TB, Utrecht, The Netherlands.
Hans C
HC
Ebbers
Aukje K
AK
Mantel-Teeuwisse
Fakhredin A
FA
Sayed-Tabatabaei
Ellen H M
EH
Moors
Huub
H
Schellekens
Hubert G M
HG
Leufkens
D016907:Adverse Drug Reaction Reporting Systems; D001688:Biological Products / Q000009:adverse effects*; D004348:Drug Labeling; D006801:Humans; D011358:Product Surveillance, Postmarketing
D001688:Biological Products