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 is intended to provide applicants with a clear understanding of which requirements Swissmedic must comply with to process their applications promptly and efficiently. This guidance is valid for the authorisation of biosimilars, variations thereto and new therapeutic indications, provided these variations are already approved for the reference product.
An applicant must prove that the biosimilar product is sufficiently similar to a reference product based on the structure of the active substance, the pharmaceutical quality, the biological activity, the efficacy, the safety, and the immunogenicity of the product in order to exclude any clinically relevant differences.
In order to demonstrate sufficient similarity, all physicochemical and biological characteristics of the biosimilar and comparator product must be investigated, as well as clinical and preclinical trials, and a critical review will be conducted. Clinical comparability should be demonstrated in at least one relevant sensitive patient population in one indication and with one dose for which the reference product is authorised.
In order to prove that the biosimilar is similar to the reference product, comprehensive comparability studies are required, as described in the Guideline on similar biological medicinal products (CHMP/437/04 Rev. ICH Guideline Q5E and other guidelines listed in the Annex.
To obtain approval for a biosimilar, the applicant must provide complete documentation of all analytical, chemical, and pharmaceutical tests relating to the biosimilar. As well as analytical comparability studies with the comparator product, the TPLRO (Quality) should be completed.
In order to know more about the requirements regarding documentation, for comparator products etc click this LINK.
Also, check out this Information sheet of FAQ's "FAQ on in vitro diagnostic medical device notifications" that was released on 24 November 2026 .