On July 30, 2026, FDA issued a draft guidance (here) titled Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts Guidance for Industry. FDA goes into detail regarding what they term “presentation” (container closure systems (e.g., vials) and device constituent parts of combination products) and describes how firms should address both the devices and their constituent parts as they relate to the use of the proposed biosimilar product.
The draft guidance notes that “[T]he proposed presentation cannot result in a condition of use that has not been previously approved for the reference product or a dosage form, strength, or route of administration that is not the same as the reference product” (for instance, the introduction of a device that delivers a subcutaneous injection when the original reference product is an intramuscular injection).
The guidance states: “To meet the standard for interchangeability, an applicant must provide sufficient information to demonstrate biosimilarity and also to demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch”.
The guidance uses similar language that is seen in the development of a generic product constituted with a device component which is found to be bioequivalent to its reference listed drug. That is “an interchangeable biosimilar product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. Differences in the user interface between the proposed interchangeable biosimilar combination product and its reference product may raise uncertainty about whether the difference(s) would affect the ability of end users to use the interchangeable biosimilar product when it is substituted for the reference product without the intervention of the health care provider who prescribed the reference product”.
“The guidance provides guidance for sponsors to determine the types of data and information related to a proposed presentation that might be necessary to support licensure as a biosimilar or interchangeable product. The considerations described in this guidance are intended to provide clarity and support flexibility where appropriate and adequately justified.” The guidance explains the type of comparative testing of the device and user interface and kind of evaluation the Agency is contemplating.
The FDA says: “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 guidance was developed based on the FDA’s BsUFA III commitment letter to issue guidance on this topic.
