title: Characteristics of product recalls of biopharmaceuticals and small-molecule drugs in the USA.
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.
authors.affiliation: 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.
authors.forename: Hans C
authors.initials: HC
authors.lastname: Ebbers
authors.affiliation: Utrecht University, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht, The Netherlands.
authors.forename: Nina Fuentes
authors.initials: NF
authors.lastname: de Tienda
authors.affiliation: Medicines Evaluation Board (CBG-MEB), Utrecht, The Netherlands.
authors.forename: Marcel C
authors.initials: MC
authors.lastname: Hoefnagel
authors.affiliation: Medicines Evaluation Board (CBG-MEB), Utrecht, The Netherlands.
authors.forename: Ria
authors.initials: R
authors.lastname: Nibbeling
authors.affiliation: 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.
authors.forename: Aukje K
authors.initials: AK
authors.lastname: Mantel-Teeuwisse
mesh_terms: D001688:Biological Products; D056736:Drug Recalls; D004364:Pharmaceutical Preparations; D011786:Quality Control; D014481:United States
chemical_list: D001688:Biological Products; D004364:Pharmaceutical Preparations