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

Issue Date: August 3, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Biosimilars
Status: Draft

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This draft guidance is intended to help applicants develop container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products. This draft guidance expands on and clarifies the Agency’s recommendations and expectations regarding the development of delivery devices and container closure systems described in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.

Download the Guidance Document

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