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Swissmedic: Revision of the Guidance document Authorisation Biosimilar

1 October 2026

Swissmedic: Revision of the Guidance document Authorisation Biosimilar

Swissmedic has revised its Guidance document Authorisation Biosimilar in line with the finalised EMA Reflection paper on a tailored clinical approach in biosimilar development. The revised guidance document comes into effect on 1 October 2026.

In view of advances in analytical sciences and regulatory experience, comparative efficacy studies are no longer always required for well-characterised biological active substances. This applies where the analytical comparability assessment, combined with pharmacokinetic and appropriate safety studies, allows a more sensitive demonstration of biosimilarity. The process for extrapolating indications from the reference product to the biosimilar has also been updated. In addition, the date of revision stated in the information for healthcare professionals of a biosimilar must now match that of its reference product. Marketing authorisation holders may implement this change with the next variation application requiring an update of the medicinal product information.

For more information, see here.

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