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Biosimilars Will Get PDUFA-Style Reviews Under New User Fee Plan

 
• By Sue Sutter

FDA will have a total of 12 months to review 351(k) applications and additional time to schedule certain product development meetings under the Biosimilar User Fee Act II agreement; measures to enhance management of user fee resources and improve hiring will carry over from PDUFA VI.

FDA and industry found much to like in the Prescription Drug User Fee Act (PDUFA) program that they thought worthy of extending to biosimilar reviews, despite wanting to separate the biosimilar program from the financial constraints of its older sibling.

One of the biggest regulatory process changes proposed for the second iteration of the Biosimilar User Fee Act (BsUFA) is the extension, by two months, of the total regulatory review period for biosimilar applications, consistent with the PDUFA V "program" for new molecular entities and novel biologics

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