NOR-SWITCH study: Real world evidence on physician-led switching to biosimilars

The NOR-SWITCH results were presented yesterday at the United Gastro-Enterology week in Vienna, highlighting that the physician-led switching between medicines containing the originator and biosimilar versions (Remsima/Inflectra) of infliximab led to the absence of statistical difference in patient outcomes.

This result is consistent with the fact that biosimilar medicines are approved to be medically interchangeable with their reference product, under the supervision of a clinical decision-maker, so that individual patient factors can be duly taken into account. The NOR-SWITCH study is the largest such study to date and its results reinforce the available positive clinical evidence gathered with the use of biosimilar medicines in the last decade in Europe.

While there is a large number of ongoing physician-led switching and observational studies involving biologic medicines (originator and biosimilar), it is essential to highlight the uniqueness of the Norwegian framework in which this study was performed: the NOR-SWITCH study forms an integral part of a wider policy framework from the Norwegian government which involved all concerned stakeholders, including patients’ representatives, in the introduction of biosimilar medicines in clinical practice.

Adrian van den Hoven, Medicines for Europe Director General commented: “This study is part of the growing body of real world evidence available on EU approved biosimilar medicines which provide alternative treatment options for both physicians and patients in 5 key therapeutic areas. It reinforces the Biosimilar Medicines Group efforts to ensure acceptance of biosimilar medicines through education and real world evidence gathering”.

Source: Medicines for Europe press release