Autoinjector, Prefilled Syringe Administration of Imraldi Have Similar PK and Safety

A study published today in Drug Design, Development and Therapy investigated the pharmacokinetics (PK), safety, and tolerability of SB5, an adalimumab biosimilar sold in the European Union as Imraldi, administered via autoinjector (AI) versus a prefilled syringe (PFS), and found that the 2 administration methods were similar.

Samsung Bioepis, maker of Imraldi, has developed an AI device that aims to address some of the mobility limitations that patients with rheumatoid arthritis (RA) may have in self-administering their adalimumab with a PFS. The AI contains the same dose of the biosimilar as the PFS, and incorporates an ergonomic design and a safety feature to prevent needle-stick injuries.

In a phase 1, randomized, open-label, single-dose, parallel-group study conducted at 1 site in Belgium and 1 site in New Zealand, 109 healthy volunteers were randomized 1:1 to receive a dose of 40 mg of adalimumab by AI or PFS and were observed for 57 days.

The PK population included 94 subjects in each group. The mean serum concentration-time profiles were superimposable between the groups, and the mean values of PK parameters were similar. The 90% confidence intervals for the geometric least squares mean ratios of AUC_inf, AUC_last, and C_max ranged from 0.9503 to 1.2240, and fell within the predefined equivalence margin of 0.8 to 1.25.

The safety group included 95 subjects in the AI group and 94 subjects from the PFS group. The percentage of subjects who had treatment-emergent adverse events (TEAEs) was similar between groups, with 68.4% of the AI group and 60.6% of the PFS group having a TEAE, and with upper respiratory tract infection the most commonly reported. Few local injection site reactions (ISRs) were observed in either group, and most were mild. The most frequently reported ISR was redness on day 1.

The authors concluded that, in healthy volunteers who received single doses of Imraldi, the AI and PFS demonstrated similar PK, safety, and injection site assessments. These results suggest that there would be no clinical differences between the 2 administration methods in terms of safety and efficacy, and that the AI represents an alternative delivery option to the PFS.

Reference

Shin D, Lee Y, Jeong D, Ellis-Pegler R. Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects. Drug Des Devel Ther. 2018;12:3799-3805. doi: 10.2147/DDDT.S169082.