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Switzerland's SwissMedic: Guidance on Authorisation Biosimilar

Yesterday (21 June 2023) Switzerland's Swissmedic released an updated guidance on "Authorisation Biosimilar" which specifies the conditions under which Swissmedic grants the Authorisation for Biosimilars.

SwissMedic is the national authority responsible for approving and overseeing the use of drugs and medical devices in Switzerland. SwissMedic follows the guidelines set forth by the European Medicines Agency (EMA) when it comes to the approval process for biosimilar products.

As per Swissmedic, A biosimilar is a biological medicinal product having sufficient similarity with a reference product authorised by Swissmedic and which refers to its documentation (Art. 4 para. 1 let. anovies TPA).

This guidance describes:

  • the requirements regarding the authorisation of biosimilars in Switzerland

  • the valid regulatory framework conditions

  • the justifications required in the case of requests to submit simplified documentation

  • the requirements concerning the documentation to be submitted in the authorisation application

This guidance document applies to the authorisation of biosimilars and their variations, as well as new therapeutic indications, provided the variations are approved for the reference product.

In order to be approved, a biosimilar must demonstrate that it is sufficiently similar to a reference product in terms of structure, pharmaceutical quality, biological activity, efficacy, safety, and immunogenicity in order to exclude any clinically relevant differences.

To know more extensively about the requirements and the documents to be submitted for authorisation of the biosimilars click this LINK.


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