Work

Pharmacokinetic Comparability of ABP 654, a Biosimilar to Ustekinumab, Administered Either via Prefilled Syringe or Autoinjector in Healthy Adults: Results from a Randomized, Open‐Label, Parallel‐Group Study

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: ABP 654, a biosimilar to ustekinumab reference product, is available in a prefilled syringe (PFS) for subcutaneous (SC) use. The ABP 654 autoinjector pen (AIP) has recently been developed with an aim to improve the injection experience for patients and caregivers. This study was designed to assess the similarity of pharmacokinetics (PK), safety, and immunogenicity of a 90‐mg SC injection of ABP 654 administered via PFS or AIP in healthy volunteers. A total of 156 adults were randomized at a ratio of 1:1. PK bioequivalence was established between the PFS and AIP groups based on the 90% CIs of the geometric mean ratios for the primary PK endpoints of maximum observed serum concentration (C max ) and area under the serum concentration–time curve from time 0 extrapolated to infinity (AUC inf ) being contained within the prespecified margin of 0.8 to 1.25. The frequency, type, and severity of adverse events as well as the incidence of antidrug antibodies were similar between the PFS and AIP groups. Overall, the results support a conclusion of PK bioequivalency as well as comparable safety and immunogenicity of ABP 654 administered via PFS and AIP.

Source: Clinical Pharmacology in Drug Development

DOI: 10.1002/cpdd.70031