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Drug Discov Today. 2016 Apr;21(4):536-9. doi: 10.1016/j.drudis.2015.10.020. Epub 2015 Nov 11.

Characteristics of product recalls of biopharmaceuticals and small-molecule drugs in the USA.

Author information

1
Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht, The Netherlands; Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Department of Pharmaceutics, Utrecht, The Netherlands.
2
Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht, The Netherlands.
3
Medicines Evaluation Board (CBG-MEB), Utrecht, The Netherlands.
4
Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht, The Netherlands. Electronic address: A.K.mantel@uu.nl.

Abstract

Compared with chemically synthesized small-molecule drugs, the manufacturing process of biopharmaceuticals is more complex. Unexpected changes to product characteristics following manufacturing changes have given rise to calls for robust systems to monitor the postauthorization safety of biopharmaceuticals. We compared quality-related product recalls in the USA of biopharmaceuticals and of small molecules. Although the reasons for recalls for biopharmaceuticals differed from those for small molecules, adverse events were rarely reported. The relative contribution of recalls that could cause serious adverse health consequences was not greater for biopharmaceuticals than for small molecules. Therefore, these data do not give rise to concerns that biopharmaceuticals are more frequently associated with unexpected safety concerns.

PMID:
26552336
DOI:
10.1016/j.drudis.2015.10.020
[Indexed for MEDLINE]

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