Swiss Biosimilars Update Embraces Foreign Comparators

 
• By Aidan Fry
  
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Switzerland’s regulatory agency is open to accepting foreign comparator products for biosimilar applications. But bridging studies are likely to be required, its latest guideline suggests.

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European and US reference biologics will be accepted by Switzerland's medicines regulatory for biocomparability exercises, but bridging studies may be necessary • Source: Shutterstock

Using a foreign comparator product in biosimilar applications, rather than referring to the Swiss-authorized reference product, is appropriate, Switzerland’s medicines agency, Swissmedic, has clarified in an update to its overarching biosimilar guideline. The revised guidance document, in force from 29 May, also now explicitly includes low molecular weight heparins (LMWHs) such as enoxaparin within the scope of its regulatory framework for biosimilars.

Section 5.4.1 of the guideline, discussing the comprehensive comparability exercise, recommends using a single comparator product. “This should preferably be...

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