Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts July 2026 ++

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biosimilar-and-interchangeable-biosimilar-products-considerations-container-closure-systems-and?utm_medium=email&utm_source=govdelivery FDA Issues Draft Guidance for Industry, “Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts” Today, FDA released a draft guidance for industry “Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts.” In this draft guidance, FDA outlines its recommendations for proposed biosimilar and interchangeable biosimilar products regarding the development of container closure systems (e.g., vials) and device constituent parts of combination products (e.g., delivery devices that contain the biological product such as prefilled syringes and autoinjectors). This draft guidance expands on and clarifies the Agency’s recommendations and expectations regarding the development of delivery devices and container closure systems described in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 titled “Questions and Answers on Biosimilar Development and the BPCI Act” and the guidance for industry titled “Considerations in Demonstrating Interchangeability With a Reference Product.” Available guidance regarding the development of delivery devices and container closure systems was limited in scope and did not provide detailed recommendations regarding the human factors related considerations for proposed biosimilar and interchangeable biosimilar products. This draft guidance addresses these gaps and describes a framework for the types of data and information that may be necessary to support licensure as a biosimilar or interchangeable biosimilar product. This draft guidance supports FDA’s efforts to promote competition, reduce biosimilar and interchangeable biosimilar development costs, decrease regulatory burden, and increase patient access to biologic medications while ensuring that differences in container closure systems or devices do not compromise safety or effectiveness. This action also relates to FDA's BsUFA III commitment to issue guidance on this topic. For instructions on how to submit comments on the draft guidance, see the Federal Register Notice. For more information about biosimilars visit: www.fda.gov/biosimilars Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry March 2026 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-biosimilar-development-and-bpci-act?utm_medium=email&utm_source=govdelivery