Swissmedic is guided by the EMA Draft Reflection paper on a tailored clinical approach in biosimilar development as the state-of-the-art in science and technology and supports the main thrust of the paper.
Swissmedic's stance regarding the EMA Draft Reflection paper on a tailored clinical approach in biosimilar development
01.03.2026
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).
The currently required scientific proof of sufficient similarity encompasses quality data (analytical comparative studies), non-clinical in vitro and in vivo data, and comparative pharmacokinetic, pharmacodynamic, safety and efficacy studies.
In view of the comprehensive regulatory experience gained to date, the need for and — particularly for biological medicinal products with a clear mechanism of action — the significance of specific clinical efficacy and safety data is being reassessed. The general need for comparative efficacy studies (CES) is currently being reviewed worldwide, and Swissmedic is also participating in this review.
The EMA Draft Reflection paper on a tailored clinical approach in biosimilar development is expected to be finalised in mid 2026. Swissmedic agrees with the scientific and regulatory considerations outlined in the Reflection Paper and is already applying these principles.
Swissmedic already accepts new authorisation applications for biosimilars with authorisation documentation that does not include data on comparative efficacy studies (CES). Please justify this in the cover letter and enclose all available Scientific Advices from the EMA and the US FDA with the application.
As soon as the final version of the EMA Reflection Paper is issued, Swissmedic will adapt its Guidance document Authorisation Biosimilar accordingly.
The document "Questions and answers on the authorisation of biosimilars" has already been updated and can be viewed via the link below.