The FDA has issued a draft guidance for industry on how sponsors should develop container closure systems and device constituent parts for proposed biosimilar and interchangeable biosimilar products. The document, Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts, expands on the agency’s earlier recommendations on delivery devices and packaging for biosimilars.
FDA said the draft guidance clarifies expectations for products such as vials, prefilled syringes and autoinjectors, and addresses gaps in prior guidance on human factors and device-related considerations. The agency said applicants may need to submit information on the design of the container closure system and device constituent parts, including data from extractable and leachable studies, performance testing and stability studies.
The guidance also outlines comparative analyses sponsors should use to assess differences between a proposed product and its reference product. These include a physical comparison of the device part, a comparative task analysis, and a side-by-side labeling comparison. FDA said some design differences may be acceptable, but they cannot create a new condition of use, or change the dosage form, strength or route of administration from the reference product.
According to FDA, the draft guidance is intended to support biosimilar competition, reduce development costs and regulatory burden, and improve patient access to biologic medicines while preserving safety and effectiveness. The action also fulfills an FDA commitment under BsUFA III.
The draft guidance is available for public comment, and FDA said it is meant to help applicants build a clearer, more predictable path toward licensure for biosimilar and interchangeable biosimilar combination products.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!