Design Differences and Usability Risks in GLP-1 Pen Injectors: A Comparative Study of a Generic and Reference Device

Area of Science:

• Pharmaceutical Sciences
• Biotechnology
• Medical Device Engineering

Background:

• Glucagon-like peptide-1 (GLP-1) receptor agonists are crucial for managing type 2 diabetes.
• The development of generic combination products requires rigorous evaluation of delivery devices.
• Ensuring seamless substitution of delivery devices is key for Abbreviated New Drug Application (ANDA) submissions.

Purpose of the Study:

• To assess the usability and potential substitutability of a proposed generic GLP-1 receptor agonist injector.
• To determine if the generic injector can replace the Reference Listed Drug (RLD) device without additional training.

Main Methods:

• A comparative Human Factors study involved 14 participants (patients and caregivers) experienced with the RLD.
• Participants simulated critical tasks using both the generic and RLD delivery devices.
• Data collected included use error rates, observational data, and subjective feedback on ease of use and acceptability.

Main Results:

• The generic injector had a slightly higher use error rate (79%) versus the RLD (71%), with most errors not device-specific.
• 93% of participants showed similar usability profiles across both devices.
• Design differences were minor, with errors quickly resolved, indicating a rapid learning effect; 87% were comfortable switching devices.

Conclusions:

• The proposed generic GLP-1 injector demonstrates comparable usability to the RLD pen, posing no additional risks.
• Observed use errors were minimal, quickly resolved, and likely to have limited clinical impact.
• Findings support the potential substitutability of the generic device for ANDA submissions, aiding regulatory de-risking.