Biosimilars already approved and in development

Abstract

As of mid-2017, 10 tumour necrosis factor inhibitors (four for etanercept and three each for adalimumab and infliximab) and a first rituximab biosimilar are on the market, and a considerable number more are in various stages of development. The clinical trials of biosimilars, which have included long term extensions, have used various designs to look at switching between originator and biosimilar products, with reassuring results for clinical practice. For the infliximab biosimilar CT-P13 in particular, several studies have examined non-medical switching in real world practice. The results suggest that switching does not compromise safety, efficacy, or immunogenicity. However, additional data from clinical and real world switching studies, especially of switching between two or more biosimilars, are needed, as is continuing pharmacovigilance with larger databases to fill remaining gaps in the evidence. As biosimilar development continues, innovations in formulation and drug delivery technology may become of increasing interest.