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FDAnews Drug Daily Bulletin
Oct. 24, 2012 | Vol. 9 No. 209
EMA Allows Biosimilar Sponsors to Reference Non-EU Products in Applications
The European Medicines Agency (EMA) will soon allow biosimilars sponsors to reference biologics made outside the European Economic Area (EEA) in some preclinical and clinical studies required for approval. Biosimilar sponsors that use a non-EEA-sourced biologic would need to establish the reference product is representative of the biologic approved in the EEA, using an extensive analytical comparison, the EMA said.
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