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Biosimilars Development In EU Could Get Easier; EC Mulls Accepting Outside Data

 
• By Faraz Kermani

Industry applauds a suggestion by a senior healthcare representative that the European Commission could re-examine the overarching guideline on biosimilars to promote global development, but growth ultimately will be determined by greater worldwide harmonization.

The European Commission has given the clearest indication yet that it is ready to consider altering its regulatory framework on biosimilar medicinal products so that comparability data may be sourced from a reference product outside the EU. This groundbreaking declaration by Nils Behrndt, deputy head of cabinet at the European Commission’s Healthcare Directorate, represents a massive boost for the global development of biosimilar medicines.

Against the backdrop of the recent development in the U.S., the EU’s potential move could see companies racing to break into this market sector ([A#00120213028]). But on closer examination...

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