DOI: 10.6084/m9.figshare.28512394.v1
title: Pharmacokinetics and safety of CT‑P39 via auto-injector are comparable to reference omalizumab via pre-filled syringe

description: To demonstrate pharmacokinetic equivalence of CT‑P39 administered via auto-injector (CT‑P39 AI) and European Union–approved reference omalizumab via pre-filled syringe (EU-OMA PFS) in healthy Japanese adults. This open-label, Phase 1 study randomized participants (1:1) to a single 150 mg/mL dose of CT‑P39 AI or EU-OMA PFS. The primary endpoint was pharmacokinetic equivalence per area under the concentration–time curve from time zero to infinity (AUC<sub>0–inf</sub>) and maximum serum concentration (C<sub>max</sub>). Equivalence was concluded if the 90% confidence intervals (CIs) for the ratios of geometric least-squares means (gLSMs) were contained within the predefined 80–125% equivalence margin. Secondary endpoints comprised additional pharmacokinetics, pharmacodynamics, safety, and immunogenicity. Overall, 65 and 64 individuals were randomized to CT‑P39 AI and EU-OMA PFS, respectively. Pharmacokinetic equivalence between CT‑P39 AI and EU-OMA PFS was demonstrated for both AUC<sub>0–inf</sub> (ratio of gLSMs [90% CI] 101.66 [95.31–108.45]) and C<sub>max</sub> (93.91 [87.20–101.14]). Thirty-nine (60.0%; CT‑P39 AI) and 32 (50.8%; EU-OMA PFS) participants experienced treatment-emergent adverse events (TEAEs) with no serious TEAEs. Secondary endpoints were comparable between groups. CT‑P39 AI was pharmacokinetically equivalent to EU-OMA PFS following a single dose in healthy Japanese individuals; pharmacodynamics, safety, and immunogenicity were comparable. <b>What is this article about?</b> A biosimilar is a medicinal product that is a highly similar copy of an original (“reference”) medicine. Biosimilars are typically less expensive, so their use over reference medicines may increase patient access to treatment. CT‑P39 is a biosimilar determined by the European Medicines Agency to be highly similar to reference omalizumab, and approved to treat the same conditions, including asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. CT‑P39 is approved for injection by a pre-filled syringe (PFS) device. An auto-injector (AI) device, which may be easier for patients to self-inject, has also been developed. In this study, healthy Japanese adults were given a single dose of either CT‑P39 administered via an AI or reference omalizumab administered via a PFS. <b>What were the results?</b> Pharmacokinetics (what the body does to the drug – i.e. drug absorption, distribution, metabolism, and excretion), pharmacodynamics (the effect of the drug on the body), safety (the occurrence of side effects), and immunogenicity (the occurrence of immune responses to the drug) were comparable between the two groups. <b>What do the results of the study mean?</b> Previous pharmacokinetic studies with CT‑P39 were conducted predominantly in healthy White adults. The current study's findings support generalizing the conclusions about CT‑P39 similarity to reference omalizumab, as well as demonstrating that the different injection device did not affect the delivery or safety of the medication.