De-risking FDA Abbreviated New Drug Application (ANDA) Submissions: BD Physioject™ Disposable Autoinjector For Tirzepatide

The BD Physioject™ Disposable Autoinjector for Tirzepatide provides a patient-centric, reliable solution designed to help de-risk Abbreviated New Drug Application (ANDA) submissions in the U.S. market. To gain FDA approval for a generic drug-device combination product, manufacturers must demonstrate that their product closely matches the Reference Listed Drug (RLD) in usability, performance, and design. BD proactively supports this requirement through a comprehensive approach involving task analysis, physical comparison, and Comparative Use Human Factors (CUHF) studies.

During a formative CUHF study, 15 participants—representing patients and caregivers—conducted simulated injections using both the BD Physioject™ and the RLD autoinjector. The study highlighted two “Other Design Differences,” particularly the mechanism for unlocking the injection button and the type of indicator for injection completion. Despite these differences, the study found that 100% of participants successfully unlocked the BD device on first use, with comparable use error rates between the two devices (BD: 20%, RLD: 13%). Furthermore, 80% of participants demonstrated similar performance across both devices, and 13 out of 15 were willing to switch between the BD and RLD autoinjectors.

The BD Physioject™ platform is already approved for use with more than nine medications globally and features customizable components to meet varied pharmaceutical and branding needs. With its validated design, robust usability data, and proactive regulatory strategy, the BD Physioject™ Autoinjector is positioned as a valuable partner for companies navigating the ANDA pathway for Tirzepatide or similar therapies.