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Biosimilars Law Blog

Tag Archives: biological product development

Posted in News & Events

FDA has announced rates for biosimilar user fees for FY 2013

The biosimilar biological product development (BPD) fee has been set at $195,880 (10% of the full application fee).  This is the amount due when a sponsor submits an investigational new drug (IND) application for a biosimilar (or within 5 days of FDA granting a BDP meeting request – whichever occurs first). When a sponsor is