8.3.1 “If a comparator product from a foreign country (EU, USA, Japan or Canada) is used, the equivalence of the foreign comparator product with the Swiss reference product must be demonstrated in order to prove that the investigation results can be transferred to the reference product.”
For main studies on the comprehensive comparability with the biosimilar, Swissmedic to date has only accepted the reference product from Switzerland or a product from the EU. For supplementary studies, comparator products from Japan have also been accepted.
Another new aspect to consider ist that as of now an Environmental Risk Assessment (ERA) is compulsatory for biosimilar submission to Swissmedic.
8.1.1 “When applying for authorisation of biosimilars, an Environmental Risk Assessment (ERA) must be submitted or else an appropriate reason given for not submitting one”.
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