CTD Section 1.18.2 Report
Summary
Section Name:
Biological Proper Name Suffix
Section Code:
1.18.2
Module Number:
1
Description:
This section is for biosimilar products, which may share a core name with the original biologic product, but have a unique suffix (4 random letters separated from the core name by a hyphen)
Submission Timing
At any point up to and including marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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