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In this section: Biosimilar User Fee Amendments

Guidance Documents and MAPPs (BsUFA)

MaPPs (Manual of Policies and Procedures)

MAPP 6050.2 Effect of Failure to Pay BsUFA Fees, Issued 12/3/2021

Guidance Documents

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017
Labeling for Biosimilar Products (PDF - 143KB)
Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (PDF - 139KB)
Search "Biosimilar" on the Guidances for Drugs webpage for more Biosimilar guidances.

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