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Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts." This draft guidance is intended to help applicants develop container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products. This draft guidance expands on and clarifies the Agency's recommendations and expectations regarding the development of delivery devices and container closure systems described in Q.I.4 of the guidance for industry entitled "Questions and Answers on Biosimilar Development and the BPCI Act" and the guidance for industry entitled "Considerations in Demonstrating Interchangeability With a Reference Product" for biosimilar and interchangeable biosimilar products, respectively.
- Document type
- Notice
- Federal Register document number
- 2026-15630
- Published
- Aug 3, 2026
- Action
- Notice of availability.
- Docket
- FDA-2026-D-4272
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by October 2, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- CMC (chemistry, manufacturing & controls) Vaccines / biologics Medical devices
Source: Federal Register API, document 2026-15630. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.