PROJECT

NOR-SWITCH

Switching from originator product to biosimilar in patients with inflammatory diseases of the joints, gut or skin

project manager

phd fellow

About the project

The NOR-SWITCH study was led by Diakonhjemmet Hospital and investigated the transition from originator infliximab to biosimilar CT-P13 in patients on stable long-term treatment, with regard to efficacy, safety and immunogenicity. The study is a randomized, non-inferiority, double-blind study with 52 weeks of follow-up and a 26-week extension study.

Who can participate?

The study has been completed.

Adult patients from all six disease indications for infliximab, on stable treatment with infliximab originator drug and treated for at least 6 months, were eligible.

Project arrangement

Patients from 40 Norwegian study centers were randomized 1:1 to either continue the original drug or switch to CT-P13 treatment, with an unchanged dosing regimen.

The primary endpoint was disease worsening during 52 weeks of follow-up. 482 patients were randomized. Disease worsening occurred in 53 (26%) patients in the originator group and 61 (30%) patients in the CT-P13 group. Switching from infliximab originator to CT-P13 was thus not inferior to continued treatment with originator. The study became a landmark by demonstrating the benefit and safety of switching from expensive originator drugs to less expensive biosimilar drugs. The main results were published in The Lancet in 2017. A 26-week extension study was published in 2019, showing continued good response and safety with infliximab biosimilar treatment after the switch.

Partners

All rights reserved © REMEDY; Illustration/portrait images © Nicolas Tourrenc/Diakonhjemmet Hospital