A Review of Adalimumab Biosimilars for the Treatment of Immune-Mediated Rheumatic Conditions

Abstract

Adalimumab is a recombinant fully human monoclonal antibody targeting soluble and transmembrane TNF alpha. It is approved for the treatment of immune-mediated rheumatic, gastroenterological, dermatological, and ophthalmological conditions and this therapeutic versatility has made it the top-selling drug worldwide since 2012. Not surprisingly, following the patent expiration of the originator drug, biopharmaceutical companies invested in the development of biosimilar versions of adalimumab and six have already received marketing authorisation: ABP 501, GP2017, and BI 695501 in Europe and in the USA (though the manufacturer of the latter requested authorisation withdrawal in Europe), and SB5, FKB327, and MSB11022 in Europe. This manuscript reviews published data on approved adalimumab biosimilars, including analytical and biofunctional results from preclinical assessments; pharmacokinetics after administration in healthy subjects (Phase I trials); and efficacy, safety, and immunogenicity from pivotal (Phase III) clinical trials. Data on switching from reference adalimumab to biosimilars, and predicted cost-savings from available budget impact models, will also be addressed.