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EMA Prepares For Biosimilar Reference Data From Non-EU Sources; U.S. Input Vital

 
• By Faraz Kermani

The EMA is preparing to accept data from non-EU sourced reference products for biosimilars, but suggests U.S. co-operation is essential to boost global development.

The European Medicines Agency is set to accept data from reference product batches sourced outside the EU for biosimilar medicines applications. The aim of this revised guidance is to keep Europe one step ahead of its rivals in a race to secure the largest share of the global biosimilars market, but at the same time, co-operation with the U.S. has been singled out by EMA as essential to further the global development of biosimilar medicinal products.

Once converted into concrete policy, the agency’s declaration in favor of reference products from third countries is has the potential...

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