Performance evaluation of an adalimumab biosimilar autoinjector and its reference device: comparative use human factors study in patients with rheumatoid arthritis and juvenile idiopathic arthritis

A Comparative Use Human Factors study was conducted to assess whether the injection success rate (SR) with biosimilar adalimumab-fkjp (Bios-ADA) autoinjector (Hulio®) is comparable to reference adalimumab (Ref-ADA) autoinjector (Humira®), accounting for design differences, including the absence of an activation button, to evaluate usability in the target patient population. A counterbalanced, multicenter study was conducted under simulated conditions, with patients completing multiple steps to administer the medication (40 mg Bios-ADA or Ref-ADA) into an injection pad using both devices. The endpoint was the overall SR for completing critical delivery system tasks with each device. A total of 55 patients (50 adults with rheumatoid arthritis and five patients with juvenile idiopathic arthritis and/or pediatric Crohn's disease) were enrolled. The overall SR for patients using the Bios-ADA autoinjector and the Ref-ADA was 92.7% (51/55) and 87.3% (48/55), respectively. Four and seven use errors were observed with the Bios-ADA and Ref-ADA autoinjectors, respectively. Bios-ADA autoinjector was non-inferior to Ref-ADA autoinjector, and design differences did not introduce clinically significant use-related risks. The Bios-ADA autoinjector can be used as a practical alternative to the Ref-ADA autoinjector from a usability perspective, with comparable overall performance during self-administration.