A biosimilar is a biological medicinal product that is sufficiently similar to a reference preparation authorised by Swissmedic and that refers to its documentation (Art. 4 para. 1 let. anovies TPA).
In its publication dated 1 March 2026, Swissmedic announced an update of the Guidance document Authorisation Biosimilar in line with the finalised EMA Reflection paper on a tailored clinical approach in biosimilar development.
Previously, the required comparability assessment included quality data (analytical comparability assessment), non-clinical in vitro data and comparative clinical studies (e.g. pharmacokinetic, pharmacodynamic, and safety and efficacy studies). Given the progress in the analytical sciences and the comprehensive regulatory experience gained, the importance of specific comparative clinical efficacy and safety data has been reevaluated. Comparative efficacy studies (CES) are now no longer always required for well characterised biological active substances if the analytical comparability assessment in combination with pharmacokinetic and appropriate safety studies enable more sensitive demonstration of sufficient similarity (biosimilarity). The process for extrapolation of indications from the reference product to the biosimilar has also been updated.
Previously, the date stated for biosimilars in the Date of revision of the text section of the Information for healthcare professionals was independent of that for their reference products. However, these dates should now match. This change can be made by marketing authorisation holders as part of the next application for variation requiring an update to the medicinal product information.
Editorial corrections and updates to links to guidelines of other authorities have also been made in the Guidance document.
The revised Guidance document Authorisation Biosimilar comes into effect on 1 October 2026.