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

Despite "other design differences", the proposed generic combination product injector demonstrated comparable usability to the RLD pen, without additional risks. Most observed use errors were not device-specific and were resolved quickly, suggesting limited clinical impact in realworld use. These findings support the potential substitutability of the proposed GLP-1 generic combination product for the RLD and contribute to de-risking the final comparative use Human Factors evaluations required for ANDA.