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

Laurie Brunet-Manquat1, Anne Combedazou2, Claire Ramus1

  • 1BD Medical-Pharmaceutical Systems, Becton Dickinson and Company, Le Pont-de-Claix, France.

PDA Journal of Pharmaceutical Science and Technology
|February 16, 2026
PubMed
Summary
This summary is machine-generated.

A new generic glucagon-like peptide-1 (GLP-1) receptor agonist injector shows comparable usability to the reference device. This suggests potential substitutability for Abbreviated New Drug Application (ANDA) submissions without additional user training.

Keywords:
Drug-delivery deviceDrug-device combination productsGenericHuman FactorsPen injectorUsability

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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.