Affordable Access

deepdyve-link
Publisher Website

The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review.

Authors
  • Barbier, Liese1
  • Ebbers, Hans C2
  • Declerck, Paul1
  • Simoens, Steven1
  • Vulto, Arnold G1, 3
  • Huys, Isabelle1
  • 1 Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium. , (Belgium)
  • 2 Medicines Evaluation Board (MEB) Agency, Utrecht, The Netherlands. , (Netherlands)
  • 3 Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, The Netherlands. , (Netherlands)
Type
Published Article
Journal
Clinical Pharmacology & Therapeutics
Publisher
Wiley (Blackwell Publishing)
Publication Date
Oct 01, 2020
Volume
108
Issue
4
Pages
734–755
Identifiers
DOI: 10.1002/cpt.1836
PMID: 32236956
Source
Medline
Language
English
License
Unknown

Abstract

To date, no consensus exists among stakeholders about switching patients between reference biological products (RPs) and biosimilars, which may have been curbing the implementation of biosimilars in clinical practice. This study synthesizes the available data on switching and assesses whether switching patients from a RP to its biosimilar or vice versa affects efficacy, safety, or immunogenicity outcomes. A total of 178 studies, in which switch outcomes from a RP to a biosimilar were reported, was identified. Data were derived from both randomized controlled trials and real-world evidence. Despite the limitations stemming from a lack of a robust design for most of the studies, the available switching data do not indicate that switching from a RP to a biosimilar is associated with any major efficacy, safety, or immunogenicity issues. Some open-label and observational studies reported increased discontinuation rates after switching, which were mainly attributed to nocebo effects. Involvement of the prescriber in any decision to switch should remain and attention should be paid to the mitigation of a potential nocebo effect. © 2020 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Report this publication

Statistics

Seen <100 times