FDA drafts guidance on container closure systems, device constituents for biosimilars
The US Food and Drug Administration (FDA) on Friday issued draft guidance to assist sponsors in providing necessary information for developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar combination products, such as prefilled syringes and autoinjectable pens.
“When developing a product for licensure under section 351(k) of the PHS Act, it is important that sponsors carefully consider the presentation of the proposed product relative to the presentation of the reference product. The 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,” FDA said.
The guidance is being issued to fulfill a commitment under the Biosimilar User Fee Act (BsUFA III).
The document expands on two previous documents: FDA’s 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.
The guidance states that “a general description of the entire presentation should be provided in the chemistry, manufacturing, and controls (CMC) section of the application. There should be complete CMC information for the proposed container closure system and any device constituent parts.” This CMC information should include extractable/leachable studies, performance testing, and stability studies.
FDA said that sponsors should also perform three types of comparative analyses to evaluate the differences in user interface design between the proposed biosimilar or interchangeable biosimilar combination product and its reference product.
These analyses should include: a physical comparison of the device constituent part with the reference product; a comparative task analysis between the proposed biosimilar or interchangeable biosimilar combination product and its reference product; a labeling comparison, which involves a side-by-side, line-by-line examination of the proposed labeling alongside that of the reference product.
FDA notes in the guidance that some design differences in how a proposed biosimilar combination product is presented compared to its reference product may be acceptable. However, these differences must not lead to a use condition that has not been previously approved for the reference product, nor can they alter the dosage form, strength, or route of administration from that of the reference product.
For instance, an applicant might obtain licensure for a proposed biosimilar combination product in a prefilled syringe or auto-injector format, even if the reference product is presented in a vial, as long as the proposed biosimilar meets the statutory standards for biosimilarity. Additionally, data from human factors studies may be required.
Yet FDA will reject licensure for a proposed biosimilar product if a design difference in its presentation results in a clinically meaningful difference in safety, purity, or potency compared to the reference product, or if there is a difference in the route of administration, dosage form, or strength.
