← FDA GUIDANCE
FDA GUIDANCE · DRAFTJuly 31, 2026

Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts

Status
Draft
Topic
Biosimilars
Issue date
July 31, 2026

This is a draftguidance — issued for comment and not for implementation. It signals FDA’s current thinking and the direction of a requirement, but the final document may change. Track the comment window on the FDA page.

CHECKING ACCESS

Checking your Professional access…

READ THE FULL GUIDANCE

The complete guidance document — every recommendation and its scope — is published by the FDA. SPEQ surfaces and indexes it for reference; the authoritative text lives on fda.gov.

View on fda.gov →
PUT THIS GUIDANCE TO WORK
Decode the standardsThe requirements this guidance interprets →Assess your quality systemBaseline against 12 GxP domains in 10 minutes →All FDA guidanceBrowse the live guidance feed →

Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.