Swissmedic updates biosimilar guidance to allow comparators sourced from the US

The Swiss Agency for Therapeutic Products (Swissmedic) has updated its rules on the comparators used in biosimilar clinical trials. For main studies on the comprehensive comparability with the biosimilar, Swissmedic has previously only accepted the reference product from Switzerland or a product from the European Union. However Swissmedic is now allowing biosimilar developers to use comparators sourced from the United States (US).

This marks a change in the policy Swissmedic established when it formally adopted biosimilar rules last year. The updated guidance adds the US to the list, but companies that choose to source comparators from the US will face additional regulatory requirements.

Swissmedic states that “if the product is obtained from the USA for the comprehensive comparability studies with the biosimilar – including safety and efficacy – three-way bridging between the biosimilar, the EU and the US comparator product must be carried out”. Companies that work with EU comparators only need to perform bridging with the Swiss reference product.

Swissmedic has also liberalised its rules on the origins of drugs used in complementary biosimilar studies. Canada joins Japan on the list of countries that can supply products for use in the clinical trials. Regardless of whether the product comes from Canada or Japan, Swissmedic expects the company to compare them to the EU product. Direct bridging to the reference product is not needed.

A further change to the guidance is that an environmental risk assessment (ERA) is now required in filings for approval of biosimilars to Swissmedic.

To view the updated guidance from Swissmedic on Authorisation of biosimilars, please click here.