FDA Releases Guidance for Industry Regarding Implementation of Biosimilar User Fee Amendments of 2017

The FDA recently announced the availability of a final guidance for industry titled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.”   This guidance concerns the implementation of BsUFA II, which as we previously reported, extends FDA’s authority to collect user fees from fiscal year (FY) 2018 to 2022.  BsUFA II authorizes the collection of three types of fees:  (1) biosimilar biological product development program (BPD) fees, (2) biosimilar biological product application fees, and (3) biosimilar biological product program fees.  BsUFA II eliminates fees for application supplements as well as for establishments.  Under BsUFA II, applicants will be assessed annual biological product program fees, rather than the biosimilar biological product fees assessed under BsUFA I.  In addition, BsUFA II eliminates the reduction of an application fee by the cumulative amount of fees paid by the applicant under the BPD program.  The guidance is available here.