Swissmedic updates biosimilar guidance to allow comparators of US origin

RAPS

11 January 2018 - The Swiss Agency for Therapeutic Products (Swissmedic) has liberalized its rules on the comparators used in biosimilar clinical trials. Swissmedic is now allowing biosimilar developers to use comparators sourced from the United States.

That marks a change in the policy Swissmedic established when it formally adopted biosimilar rules last year. At that point, Swissmedic only permitted the use of comparators from the European Union or Switzerland in the main studies of biosimilars. The updated guidance adds the US to the list, but companies that opt to source comparators from across the Atlantic will face additional regulatory requirements.

“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,” Swissmedic wrote in its updated guidance. Companies that work with EU comparators only need to perform bridging with the Swiss reference product.

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Michael Wonder

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Michael Wonder