EFPIA and EBE welcome NOR-SWITCH results as a valuable step forward

EFPIA and EBE welcome the results of the NOR-SWITCH study on biosimilar switching and acknowledge its preliminary results as a step in the right direction of robust data generation that continues to enhance physician and patient confidence in using biosimilars.

EFPIA and EBE also welcome the effort of the Norwegian authorities and investigators to initiate and carry out the NOR-SWITCH study.

The study aimed to assess disease worsening through a single switch from biologic Remicade (originator infliximab) to CT-P13 (biosimilar infliximab – Remsima/Inflectra) in disease-stable patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis. The protocol indicates the study is being ‘driven by financial motivation’ and switching patients on stable treatment will result in substantial cost savings to the Norwegian government. The preliminary results presented this week indicated that CT-P13 is not inferior to the originator in terms of disease worsening in stable patients who have been on Remicade treatment for at least six months.

The study’s conclusion is an important development that will aid physician’s in making evidence based treatment decisions for patients using infliximab. Importantly, while NOR-SWITCH provides evidence for a one way switch from Remicade to CT-P13, the study does not and cannot address the following:

• Multiple switches – switching back and forth between Remicade and a specific biosimilar, CT-P13,
• Switching between different biosimilar infliximab products, either biosimilar or originator (either in a single switch or a multiple switch)

Although the results offer a valuable source of information for physicians it is important to recognise these results are only relevant to these infliximab products. Biologics are highly complex molecules, treating patients with highly complex diseases and – and that switching stable patients is still nascent in its practice. Conclusions, therefore, from one switching study are not transferrable to all biologic molecules. Assurance needs to be provided that it is safe to switch between medicines to account for the differences between molecules, diseases and – most importantly – patients.

EFPIA and EBE note furthermore that the primary endpoint for the study is ‘disease worsening’ in the six indications studied. In the study, the different disease worsening endpoints have, however, been pooled together to calculate the overall ‘proportion of patients experiencing disease worsening’. As disease worsening is defined differently across different indications – accounting for different sensitivities, patient factors (e.g. co-morbidities) and dosing, etc. – the pooling of disease worsening endpoints means the study was not statistically powered to make conclusions on each disease individually, consequently it is a generalised result that may not be a true measure of non-inferiority for each individual indication.

EFPIA and EBE also want to re-iterate the importance of physician involvement and patient awareness as well as monitoring in switching decisions as they are made for biologics.