title: The safety of switching between therapeutic proteins.
abstract: BACKGROUND
  The approval of several biosimilars in the past years has prompted discussion on potential safety risks associated with switching to and from these products. It has been suggested that switching may lead to safety concerns. However, data is limited on the clinical effects of switching.
  
  
  METHODS
  In this review we provide an overview of data related to switching between human recombinant growth hormones, erythropoietins and granulocyte colony stimulating agents. We reviewed data from clinical trials, pharmacovigilance databases and an overview of the literature on the frequency of switching between these products. The review covers both switching between innovator products within the same product class and switching to and from biosimilars.
  
  
  CONCLUSIONS
  Data on the frequency of switching in clinical practice is scarce, but it seems most frequent for erythropoietins. We have found no evidence from clinical trial data or post marketing surveillance data that switching to and from different biopharmaceuticals leads to safety concerns.
authors: Utrecht University, Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology and Clinical Pharmacology, PO Box 80082, 3508 TB Utrecht, The Netherlands.
authors: Hans C
authors: HC
authors: Ebbers
authors: Michael
authors: M
authors: Muenzberg
authors: Huub
authors: H
authors: Schellekens
mesh_terms: D000818:Animals; D001702:Biopharmaceutics / Q000639:trends; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage / Q000009:adverse effects*; D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000639:trends; D016208:Databases, Factual / Q000639:trends; D057915:Drug Substitution / Q000009:adverse effects* / Q000639:trends; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D060735:Pharmacovigilance; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins; D004921:Erythropoietin