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EMA To Accept Non-EU…

EMA To Accept Non-EU Or Non-EEA Reference Medicinal Product RMP For Biosimilar MAAs.

European Biosimilars developers will be glad to hear that the reference product of the Originators biologic, can be purchased outside the EU for comparative pivotal studies. The decision was made public by the EMA recently and the new policy should be implemented next year 2013 in the updated overarching “similar medicinal products” guideline CHMP/437/04. With regard to the acceptance of US-sourced RMPs, a close collaboration with the FDA is foreseen to ensure harmonisation of requirements. This will be welcomed by US driven companies. Through our extensive network of approved supply partners we are be able to offer comparators from outside the EU at high quality and competitve prices.