Is there a reason for concern or is it just hype? - A systematic literature review of the clinical consequences of switching from originator biologics to biosimilars

Expert Opin Biol Ther. 2017 Aug;17(8):915-926. doi: 10.1080/14712598.2017.1341486. Epub 2017 Jun 26.


While prescribing biosimilars to patients naive to a biologic treatment is a well-accepted practice, switching clinically stable patients from an originator to a biosimilar is an issue for clinicians. Well-designed clinical trials and real-world data which study the consequences of switching from an originator biologic treatment to its biosimilar alternative are limited, especially for monoclonal antibodies. Areas covered: A systematic literature review was conducted on PubMed to identify evidence of the consequences of switching from original biologics to biosimilars. References of included papers were also scrutinized. After a title-, abstract- and full text screening, out of the 153 original hits and 77 additional ones from screening the references, 58 papers (12 empirical papers, 5 systematic reviews and 41 non-empirical papers) were included. Expert opinion: Preventing patients on biologic medicines from switching to biosimilars due to anticipated risks seems to be disproportional compared to the expected cost savings and/or improved patient access. Indeed, it is the opinion of the authors that the concern of switching to biosimilars is overhyped.

Keywords: Biosimilar; immunogenicity; patient access; risk; societal benefit; substitution; switch.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Anemia / drug therapy
  • Anemia / etiology
  • Biosimilar Pharmaceuticals / adverse effects
  • Biosimilar Pharmaceuticals / therapeutic use*
  • Databases, Factual
  • Epoetin Alfa / adverse effects
  • Epoetin Alfa / therapeutic use
  • Health Care Costs
  • Humans
  • Inflammatory Bowel Diseases / drug therapy
  • Kidney Failure, Chronic / complications
  • Neoplasms / drug therapy
  • Red-Cell Aplasia, Pure / etiology
  • Rheumatic Diseases / drug therapy
  • Risk


  • Biosimilar Pharmaceuticals
  • Epoetin Alfa