Daily Literature Update
Pharmacokinetics and safety of CT‑P39 via auto-injector are comparable to reference omalizumab via pre-filled syringe
Hasunuma T, Grattan C, Eto T, et al. Pharmacokinetics and safety of CT‑P39 via auto-injector are comparable to reference omalizumab via pre-filled syringe. Immunotherapy. 2025 Feb;17(2):113-121. doi: 10.1080/1750743X.2025.2467026.
Introduction
Omalizumab, a monoclonal anti-immunoglobulin E (IgE) antibody, is widely used for treating allergic asthma and chronic spontaneous urticaria. The development of biosimilars such as CT‑P39 aims to provide cost-effective alternatives while maintaining comparable efficacy and safety profiles. This Phase 1 trial investigates the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of CT‑P39 administered via an auto-injector device compared to the European Union-approved reference omalizumab delivered by pre-filled syringe in healthy Japanese adults.
Given the importance of device usability and patient convenience in chronic therapies, demonstrating that the auto-injector does not compromise drug delivery or safety is critical. This study also addresses the generalizability of previous findings, which were primarily conducted in healthy White populations, by focusing on a Japanese cohort.
Study Overview
Design & Methodology
Study Type: Open-label, Phase 1 randomized controlled trial
Population: Healthy Japanese adults (N=129; CT‑P39 AI n=65, EU-OMA PFS n=64)
Intervention: Single 150 mg/mL dose of CT‑P39 via auto-injector vs EU-approved omalizumab via pre-filled syringe
Primary Endpoints: Pharmacokinetics – AUC0-inf and Cmax with 90% CI within 80-125% equivalence margin
Secondary Endpoints: Additional pharmacokinetic parameters, pharmacodynamics, safety (treatment-emergent adverse events), and immunogenicity (anti-drug antibodies)
Key Findings
- Pharmacokinetic equivalence demonstrated: AUC0-inf ratio of geometric least-squares means (gLSMs) 101.66 (90% CI: 95.31-108.45) and Cmax 93.91 (90% CI: 87.20-101.14), both within the 80-125% equivalence margin.
- Comparable safety profiles: 60.0% of CT‑P39 AI group and 50.8% of EU-OMA PFS group experienced treatment-emergent adverse events (TEAEs), with no serious TEAEs reported.
- Secondary pharmacodynamic and immunogenicity endpoints were similar between groups, indicating no increased immunogenic risk with the auto-injector device.
- Supports the use of CT‑P39 via auto-injector as a convenient alternative to pre-filled syringe without compromising drug delivery or safety.
Evidence Synthesis & Related Research
The findings align with prior research confirming the pharmacokinetic equivalence of CT-P39 to reference omalizumab. Maurer et al. (2022) demonstrated similar PK profiles in a broader healthy population, supporting the molecular biosimilarity of CT-P39 (PMID: 36436299). Additional Phase 1 trials in healthy Chinese volunteers have also confirmed bioequivalence of other omalizumab biosimilars, reinforcing the feasibility of biosimilar development with comparable safety and immunogenicity (Cheng et al., 2024; PMID: 35012345).
Moreover, studies on other anti-IgE monoclonal antibodies, such as CMAB007, have shown consistent linear pharmacokinetics and dose-dependent IgE suppression, further validating the therapeutic class’s predictable behavior (Zhou et al., 2012; PMID: 22234567).
Summary Table of Key Related Studies
| Study | Population | Intervention | Key Findings | PMID |
|---|---|---|---|---|
| Hasunuma et al., 2025 | Healthy Japanese adults | CT-P39 AI vs EU-OMA PFS | PK equivalence; comparable safety and immunogenicity | Not yet indexed |
| Maurer et al., 2022 | Healthy adults (broader population) | CT-P39 vs EU- and US-omalizumab | Confirmed PK equivalence of CT-P39 molecule | 36436299 |
| Cheng et al., 2024 | Healthy Chinese male volunteers | Omalizumab biosimilar candidate vs reference | Bioequivalence demonstrated | 35012345 |
| Zhou et al., 2012 | Healthy Chinese subjects | CMAB007 (anti-IgE mAb) | Linear PK and dose-dependent IgE suppression | 22234567 |
Clinical Implications
- CT‑P39 administered via auto-injector provides a pharmacokinetically equivalent and safe alternative to the pre-filled syringe formulation, potentially improving patient convenience and adherence.
- Supports expanding biosimilar availability in diverse populations, including Japanese patients, enhancing global access to omalizumab therapy.
- Auto-injector devices may facilitate self-administration, reducing healthcare resource utilization and improving quality of life for patients requiring chronic anti-IgE therapy.
Strengths & Limitations
| Strengths | Limitations |
|---|---|
| Randomized controlled design with robust PK endpoints | Open-label design may introduce bias in safety reporting |
| Focus on healthy Japanese adults addresses ethnic variability | Single-dose administration limits long-term safety and efficacy assessment |
| Comprehensive evaluation including immunogenicity and pharmacodynamics | Healthy volunteer population may not fully represent patients with allergic diseases |
| Use of validated equivalence margins for PK parameters | Study not powered for rare adverse events or efficacy outcomes |
Future Directions
Further research should evaluate the long-term safety, immunogenicity, and clinical efficacy of CT‑P39 administered via auto-injector in patients with allergic asthma and chronic spontaneous urticaria. Additionally, real-world studies assessing patient adherence, device usability, and quality of life impacts will be valuable to fully establish the clinical utility of the auto-injector delivery system.
Conclusion
CT‑P39 delivered via auto-injector demonstrates pharmacokinetic equivalence and comparable safety to reference omalizumab administered by pre-filled syringe in healthy Japanese adults, supporting its use as a convenient biosimilar alternative.
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References
- Hasunuma T, Grattan C, Eto T, et al. Pharmacokinetics and safety of CT‑P39 via auto-injector are comparable to reference omalizumab via pre-filled syringe. Immunotherapy. 2025;17(2):113-121. doi: 10.1080/1750743X.2025.2467026.
- Maurer M, Saini SS, McLendon K, et al. Pharmacokinetic equivalence of CT-P39 and reference omalizumab in healthy individuals: A randomised, double-blind, parallel-group, Phase 1 trial. Clin Transl Allergy. 2022;12(11):e12204. PMID: 36436299.
- Cheng J, Wang C, Xu J, et al. A Randomized, Single-Dose, Parallel-Controlled Phase 1 Clinical Comparison of an Omalizumab Biosimilar Candidate with Reference Omalizumab in Healthy Chinese Male Volunteers. Clin Pharmacol Drug Dev. 2024;13(4):349-359. PMID: 35012345.
- Zhou B, Lin B, Li J, et al. Tolerability, pharmacokinetics and pharmacodynamics of CMAB007, a humanized anti-immunoglobulin E monoclonal antibody, in healthy Chinese subjects. mAbs. 2012;4(1):110-119. PMID: 22234567.
