Biosimilar User Fee Collections Climb; Application Growth Less Clear

10 Aug 2015
News

Sue Sutter @PinkSheetSutter sue.sutter@informa.com

Executive Summary

FDA plans to send out 57 invoices for annual biosimilar product development fees in fiscal year 2016, 10 more than were sent last year, but agency remains mum on how many 351(k) submissions it expects.

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BioPharmaceutical
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United States

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Regulation

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Biosimilar User Fee Collections Climb; Application Growth Less Clear

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Executive Summary

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Biosimilar Pathway Quickly Becoming Crowded In U.S.

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