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Biosimilars Law Blog

Tag Archives: investigational new drug

Posted in News & Events

Europe approves its first mAb biosimilar & FDA is handling 17 biosimilar INDs

Not surprising after the European Medicines Agency (EMA) positive opinion for two biosimilars to Remicade (infliximab) in June, the first of these was authorized in September.  Authorization of Remsima represents the first monoclonal antibody biosimilar, and the thirteenth biosimilar, authorized in the European Union. In the United States, the Food and Drug Administration is into

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