De-risking FDA Abbreviated New Drug Application (ANDA) Submissions: BD Vystra™ Disposable Pen For Liraglutide 3.0 mg

BD’s Vystra™ Disposable Pen for Liraglutide 3.0 mg represents a key advancement in supporting generic drug-device combination product development, specifically for Abbreviated New Drug Application (ANDA) submissions. The U.S. FDA requires generic products to match reference listed drugs (RLDs) in form, function, and user experience. For drug-device combinations, this includes a rigorous threshold analysis assessing physical, functional, and use interface differences.

To support these regulatory demands, BD conducted a Comparative Use Human Factors (CUHF) study between its Vystra™ pen and the liraglutide 3.0 mg RLD injector. Although two “other design differences” were identified — one involving thumb reach distance and the other concerning the dose labeling position — task analysis and formative studies showed no resulting increase in use errors. Notably, 96% of users successfully delivered medication with the Vystra™ pen, and 80% performed comparably with both devices.

This proactive evaluation, including physical comparisons and early task analysis, is part of BD’s strategy to help partners mitigate risk in the ANDA pathway. BD’s Vystra™ pen is already approved in over 40 countries and supports a wide array of therapies beyond liraglutide, including GLP-1 analogs and insulin formulations. The device uses a familiar operational sequence and user-friendly design, and BD’s PartnerPath™ Program offers preconfigured support for pharmaceutical clients pursuing generic approvals.

Through this approach, BD not only ensures regulatory alignment but also enables faster market entry for generic drug-device combination therapies, while maintaining safety and usability for patients and providers.