# Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/biosimilar-and-interchangeable-biosimilar-products-considerations-for-container-closure-systems-and-device-constituent-parts/4df667e9-a743-4341-a12b-40af5b476730

> FDA guidance document: Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts. Issue date: July 31, 2026. Get complete insights and analysis.

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## Details

- Title: Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2026-07-31
- Last Changed: 2026-07-31
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2026-D-4272">FDA-2026-D-4272</a>

## Related Documents

- [Container Closure Systems for Human Drugs and Biological Products](https://www.keypedia.com/guidances/guidance-document/container-closure-systems-for-human-drugs-and-biological-products/5e2706fd-7b11-421f-95b3-dabf73b2a467)
- [Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies: Draft Guidance for Industry](https://www.keypedia.com/guidances/guidance-document/scientific-considerations-in-demonstrating-biosimilarity-to-a-reference-product-updated-recommendations-for-assessing-the-need-for-comparative-efficacy-studies-draft-guidance-for-industry/e314875c-585b-4d6e-bb97-b1b4f4edc32d)
- [Considerations in Demonstrating Interchangeability With a Reference Product: Update](https://www.keypedia.com/guidances/guidance-document/considerations-in-demonstrating-interchangeability-with-a-reference-product-update/f154845a-a15e-4508-a634-dd22f907a286)
