The safety of switching between therapeutic proteins

Expert Opin Biol Ther. 2012 Nov;12(11):1473-85. doi: 10.1517/14712598.2012.711308. Epub 2012 Jul 31.


Introduction: 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.

Areas covered: 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.

Expert opinion: 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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Animals
  • Biopharmaceutics* / trends
  • Biosimilar Pharmaceuticals / administration & dosage
  • Biosimilar Pharmaceuticals / adverse effects*
  • Clinical Trials as Topic / adverse effects
  • Clinical Trials as Topic / trends
  • Databases, Factual / trends
  • Drug Substitution / adverse effects*
  • Drug Substitution / trends
  • Erythropoietin / administration & dosage
  • Erythropoietin / adverse effects
  • Humans
  • Pharmacovigilance
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects


  • Biosimilar Pharmaceuticals
  • Recombinant Proteins
  • Erythropoietin