CTD Section 1.3.5.2 Report
Summary
Section Name:
Patent Certification
Section Code:
1.3.5.2
Module Number:
1
Description:
Document listing relevant patents for approved biologics in the Purple Book and making this information available to biosimilar applicants
Submission Timing
Include with marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources