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

András Inotai, Christiaan P.J. Prins, Marcell Csanádi, Dinko Vitezic, Catalin Codreanu, Z. Kaló

Research output: Contribution to journalReview article

19 Citations (Scopus)

Abstract

Introduction: 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.

Original languageEnglish
Pages (from-to)915-926
Number of pages12
JournalExpert Opinion on Biological Therapy
Volume17
Issue number8
DOIs
Publication statusPublished - Aug 3 2017

Keywords

  • Biosimilar
  • immunogenicity
  • patient access
  • risk
  • societal benefit
  • substitution
  • switch

ASJC Scopus subject areas

  • Pharmacology
  • Drug Discovery
  • Clinical Biochemistry

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