Requests that FDA revise existing policy and guidance documents to confirm that, unless the Agency determines that an analytical bridge or publicly available scientific knowledge and information, or both, cannot suffice to justify the relevance of the non-U.S.-comparator, FDA will not require a 3-way pharmacokinetic (PK) study to establish a bridge between a U.S.-licensed and non-U.S. comparator | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-1098

Requests that FDA revise existing policy and guidance documents to confirm that, unless the Agency determines that an analytical bridge or publicly available scientific knowledge and information, or both, cannot suffice to justify the relevance of the non-U.S.-comparator, FDA will not require a 3-way pharmacokinetic (PK) study to establish a bridge between a U.S.-licensed and non-U.S. comparator

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensApr 18, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to The Biosimilars Forum	Mar 9, 2026	--

Keywords

CDER

Citizen Petition

The Biosimilars Forum

Requests that FDA revise existing policy and

guidance documents to confirm that, unless the

Agency determines that an analytical bridge or

publicly available scientific knowledge and

information, or both, cannot suffice to justify

Data from Regulations.gov