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

The BD Vystra™ Disposable Pen for Semaglutide is a generic drug-device combination product developed to deliver semaglutide for conditions such as diabetes and obesity. It is designed to meet U.S. FDA requirements for Abbreviated New Drug Application (ANDA) submissions, which allow generic manufacturers to use existing clinical data if their product matches the innovator’s in form, function, and intended use. The FDA’s 2017 draft guidance emphasizes the importance of evaluating user interface differences between generic and reference listed drug (RLD) devices through physical comparison, task analysis, and human factors studies.

BD’s approach included a comparative use human factors (CUHF) study, involving both patients and caregivers, to assess usability and error rates between the BD Vystra™ pen and the RLD pen. The study found that while the operational sequence was the same, two notable design differences were identified: the dose set knob’s movement and the thumb reach distance for injection. These differences could affect user perception and potentially lead to dosing errors or injection difficulties, especially for those accustomed to the RLD device. Despite these differences, the study reported that 93% of participants performed similarly on both devices, and 86% successfully delivered medication with the BD Vystra™ pen, with no use errors directly linked to the design changes.

The BD Vystra™ pen is available in multiple configurations for various therapies and is approved in over 40 countries. BD’s proactive, multi-pronged evaluation strategy aims to de-risk ANDA submissions and support pharmaceutical partners in bringing generic drug-device combinations to market efficiently.