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FDAnews Drug Daily Bulletin
Oct. 15, 2012 | Vol. 9 No. 202
EMA: Biosimilars Sponsors Can Reference Non-EU Products
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. Sponsors that use a non-EEA-sourced biologic would need to establish that the reference product is representative of the biologic approved in the EEA, using an extensive analytical comparison, the EMA said.
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