Biosimilars in chronic inflammatory diseases: facts and remaining questions 5 years after their introduction in Europe. (1st February 2022)

• Record Type: Journal Article
• Authors: Agboton, Christian; Salameh, Joseph
• Is Part Of: Expert opinion on biological therapy. Volume 22:Number 2(2022)
• Page Start: 157
• Page End: 167
• Publication Date: 2022-02-01
• Subjects: Access -- adalimumab -- antibodies -- anti-inflammatory -- biosimilars -- Europe -- immunogenicity -- infliximab -- switch; Gene therapy -- Periodicals; Protein drugs -- Periodicals; Peptide drugs -- Periodicals; Immunotherapy -- Periodicals; Drug delivery systems -- Periodicals; 615.5
• DOI: 10.1080/14712598.2021.1963435
• Languages: English
• ISSNs: 1471-2598

Abstract

ABSTRACT: Introduction: Five years after the launch of the first infliximab biosimilar, biologics have found their place in the treatment of chronic inflammatory conditions, but there are remaining questions. This is a review of the introduction of antibody biosimilars in Europe; the reasons for their success and how biosimilar hesitancy was quailed. Areas covered: We provide an overview of the concepts of biosimilarity, extrapolation, and interchangeability, using examples in rheumatology and gastroenterology for illustration. A review of the evidence collected from switching studies using robust designs is included. Remaining questions such as 'inter-switching' are also discussed. Expert opinion: Biosimilars have democratized access to powerful medicines. Efficacy and safety studies provided reassuring data, but knowledge gaps persist. The availability of so-called 'bio-betters' might open new avenues and change clinical practice.