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REGULATORY UPDATE
Revision of the Guidance document Authorisation Biosimilar
Published: 10/1/2026Detected: 10/1/2026

Summary preview

Revision of the Swissmedic guidance for authorisation of biosimilars may refine the regulatory expectations for demonstrating biosimilarity, including how applicants structure supporting evidence.

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immunology
manufacturing
quality
clinical
safety
labeling
#biosimilar
#Swissmedic
#authorisation
#biosimilarity
#comparability exercise

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