Scientific data and clinical decision making – the NOR-SWITCH Study
EuropaBio's official position on the NOR-SWITCH study.
On 18 October 2016 during the United European Gastroenterology Week in Vienna, Austria the results of the NOR-SWITCH Study were first presented.
With more than 20 biosimilars approved by the European Commission today, the question whether stable, i.e., well-treated and controlled patients can be safely switched from a biologic reference product to a biosimilar without experiencing any difference compared to if they had remained on their original treatment, has been an ongoing debate.
EuropaBio welcomes the initiative of the Norwegian Parliamenti to fund the NOR-SWITCH study, which provides important additional data that will continue to help physicians make science based decisions for their patients. EuropaBio would like to contribute to the debate and the conclusions which can be drawn from the NOR-SWITCH study. The NOR-SWITCH study has its merits in terms of the number of patients included and the number of diseases studied, and it is the first double-blind, randomized controlled switching study from originator infliximab (Remicade) to CT-P13 biosimilar infliximab (Remsima/Inflectra).
EuropaBio notes that:
- It is important to ensure statistical significance across disease states, especially where concomitant medicines, comorbidities and primary endpoints differ. This study was not powered to provide definite conclusions about the effects of a single switch across any of the specific indications studied.
- The NOR-SWITCH study provides new data for one-way switching from Remicade to CT-P13 biosimilar infliximab (Inflectra/Remsima) and thereby offers a valuable source of information for physicians. However, EuropaBio emphasizes that the study specifically looks at a one-way switch of patients from Remicade to Remsima. The results from this study cannot be applied to other originator molecules and their biosimilars or to other biosimilars of Remicade.
- The NOR-SWITCH study does not address multiple switches between Remicade and Remsima, or potential additional switches to other biosimilars of Remicade. Therefore, the NOR-SWITCH study is not reflective of potential future clinical practices, which may include such scenarios.
“EuropaBio believes that for stable and well-treated patients, the specific therapeutic needs of the patient and the potential impact on efficacy and safety when changing treatment should always be taken into consideration. Any decision to switch a stable patient should be a clinical decision made by the treating physician based on scientific evidence and in consultation with the patient”, says Ronald Jager, Director Healthcare Biotechnology at EuropaBio.
i In its 2014 budget, the Norwegian Parliament (Storting) allocated NOK 20 million (€ 2.5 million) to conduct a clinical study in Norway to document the consequences of switching patients from an originator product (Remicade) to a biosimilar product (Remsima). The primary endpoint of the NOR-Switch study is the occurrence of disease worsening in the six studied indications, ie, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis. The NOR-Switch study was carried out through collaboration between the regional health trusts and was conducted in different hospitals across Norway. The number of patients enrolled in the study was 481 and study duration was 12 months.