Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects

This open‐label, single‐dose, randomized, parallel‐group, 2‐arm phase 1 bioequivalence (BE) study assessed the pharmacokinetics (PK), safety, and tolerability of PF‐06410293 (ADL‐PF), an adalimumab (ADL) biosimilar, following administration by prefilled pen (PFP) or prefilled syringe (PFS). A total of 164 healthy adult subjects were randomized (1:1) to receive ADL‐PF (40 mg subcutaneously) in the lower abdomen or upper anterior thigh by PFS or PFP; 163 subjects were included in the primary PK analysis. The concentration‐time profiles of the ADL‐PF PFS and PFP treatment arms were similar. The 90% confidence intervals for the test/reference ratios of the primary end points (area under the serum concentration‐time profile from time 0 to 2 weeks after dosing and maximum observed serum concentration) fell within the 80.00%‐125.00% prespecified margin for BE. Comparable numbers of subjects experienced adverse events (AEs) between treatment groups, and injection‐site pain was similar at all times and for the 2 injection‐site locations. This study demonstrated the BE of ADL‐PF following subcutaneous administration using either a PFS or PFP device. ADL‐PF by PFS or PFP injection was well tolerated, with the distribution of AEs, including injection‐site reactions, being similar between treatment arms.