The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts." This draft guidance is intended to help applicants develop container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products. This draft guidance expands on and clarifies the Agency's recommendations and expectations regarding the development of delivery devices and container closure systems described in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.
US Federal Register - FDA Guidance Notices · August 03, 2026
Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry
Original title: Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability
FDA draft guidance clarifies recommendations for developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar products.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.