The outcome of psur assessments of biopharmaceuticals

Abstract

Background: Recent changes introduced to European legislation amend the requirements for the submission of periodic safety update reports (PSURs). However, information on the outcome of PSUR assessment is lacking. Aim: To describe the outcomes of PSUR assessments.(table present) Methods: A cross sectional analysis was performed of all PSURs and PSUR assessment reports (AR) issued between July 1st 2008 and June 30th 2010 for all biopharmaceuticals centrally approved in the European Union. PSURs and PSUR ARs were obtained from the repository of the Dutch Medicines Evaluation Board, CBG-MEB. Results: PSURs and PSUR ARs were collected for 70 products. Most products in the sample belonged to the ATC group of antineoplastic and immunomodulating agents (n = 26, 37.1%). Of the 70 PSURs included in the sample 26 (37%) covered a period of 6 months, 24 (34%) a period of 1 year and 20 (29%) a period of more than 1 year. The most common outcome of PSUR assessment was monitoring a possible safety issue, which was requested in 55 (79%) of all ARs. Of these, 23 (42%) included new safety concerns not identified before. New safety concerns were identified in 35% of the PSURs that were issued within 5 years of the international birth date (IBD) of the product, and in 40% of the PSURs submitted after 5 years of the IBD (p = 0.795). Cumulative reviews of data relating to a possible safety issue were requested in 31 (44%) of the PSUR assessments and 27 (39%) of the assessments resulted in proposals and/or requests to change the Summary of Product Characteristics (SPC). The proportion of assessments resulting in SPC changes in various subgroups is presented in table I. Conclusions: PSUR assessments are an important tool in the dialogue between regulators and marketing authorization holders. PSUR assessments are involved in the safety management of both new and well established products. New safety concerns occur throughout the lifecycle of biopharmaceuticals and may occur more often for products in different therapeutic and mechanistic classes.