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Pending Biosimilars

Executive Summary

Biosimilar applications using the 351(k) pathway under review at FDA. Updated upon new submissions.

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Biosimilar User Fee Agreement Offers FDA Funding Boost, Fee Structure Overhaul

BsUFA revenue amounts and fees will be separated from PDUFA and relative contribution of each fee type to the overall pot will change; user fee revenue target for program's first year is $45m.

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