Updating of guidance document and FAQ document "Authorisation Biosimilar"

01.01.2018 - For main studies on the comprehensive comparability with the biosimilar, Swissmedic has to date only accepted the reference product from Switzerland or a product from the EU. For supplementary studies, comparator products from Japan have also been accepted.

Henceforth, the foreign comparator product for the main studies can also originate from the USA, while that for supplementary studies can originate from Canada.

Environmental Risk Assessments (ERA) are now also compulsory for biosimilar submissions to Swissmedic.

The aforementioned aspects, together with a few editorial changes and additional details, can be found in the revised documents.

https://www.swissmedic.ch/content/swissmedic/en/home/humanarzneimittel/authorisations/information/aktualisierung_wegleitung_und_faq-Dokument_zulassung_biosimilar.html