Guidance Documents and MAPPs | BsUFA

MaPPs (Manual of Policies and Procedures)

• MAPP 6050.2: Effect of Failure to Pay BsUFA Fees

Guidance Documents

• Assessing User Fees Under the Biosimilar User Fee Amendments of 2022
• Labeling for Biosimilar Products (PDF - 143 KB)
• Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (PDF - 139 KB)

Search "Biosimilar" on the Guidances for Drugs webpage for more Biosimilar guidances.