- Real world evidence on the clinical use of biosimilar medicines keeps growing and further confirms the fitness-for-purpose of the EU scientific, regulatory and legal frameworks.
- The NOR-SWITCH study represents one part of the Norwegian approach to policy-making in the field of biosimilar medicines which involves multi-stakeholder engagement as a cornerstone.
- Physician-led switching allows for a sound approach to individual patient factors.
Today at the United Gastro-Enterology (UEG) week in Vienna, the NOR-SWITCH results were presented highlighting that the physician-led switching between medicines containing the originator and biosimilar (CT-P13) versions 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 (Position Paper). 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”.
What is a medical or physician-led switch?
A switch is a decision by a physician to exchange one medicine for another medicine with the same therapeutic intent. There are several scenarios however, which all involve a clinical decision maker:
- Decision by the treating physician to exchange one medicine for another medicine with the same therapeutic intent in patients who are undergoing treatment
- In hospitals, decision is made by a multidisciplinary team always including the clinical community (therapeutic/formulary committee)
A physician-led switch can be between versions of the same active substances (i.e. originator and biosimilar, biosimilar and biosimilar) but also between medicines in the same therapeutic class (e.g. anti-TNFs). The administered medicine is to be recorded in the patient file and the patients should always be involved in decisions regarding their treatment and informed about the medicine they are prescribed or given. This systematic approach strengthens also traceability in case of any adverse drug reaction (ADRs).