ADL-018 Demonstrates Bioequivalence and Comparable Safety to Reference Omalizumab

Key Takeaways:

• In a phase 1 trial comparing ADL-018 with United States‐licensed omalizumab (US‐OMA) and European Union‐approved omalizumab (EU‐OMA), the biosimilar demonstrated pharmacokinetic (PK) equivalence.
• All 3 cohorts had similar rates of adverse events (AEs), with most being low in severity.
• These findings describe ADL-018 as a safe therapy with bioequivalence to reference omalizumab, whose efficacy will be assessed in future trials.

Omalizumab (brand name Xolair), has been approved in both the US and Europe to treat moderate to severe asthma, chronic rhinosinusitis, and chronic spontaneous urticaria. It has also been approved by the US Food and Drug Administration (FDA) to treat immunoglobulin E (IgE)-mediated food allergies.

Despite this wide approval, utilization of omalizumab remains suboptimal due to high drug costs. In response to this substantial economic burden, researchers are developing omalizumab biosimilars to reduce costs and expand access.

ADL-018, a biosimilar developed by Kashiv BioSciences, LLC is structurally similar to reference omalizumab and needs further investigation.

Study Methods and Outcomes

Researchers conducted a single-dose, double-blind, parallel phase 1 study to compare the bioequivalence and safety of ADL-018 against US‐OMA and EU‐OMA.

Treatments were administered to healthy participants in a randomized 1:1:1 ratio via a single-dose prefilled syringe (PFS) of omalizumab 150 mg/mL.

The primary outcome was bioequivalence of therapies according to PK parameters, including the concentration-time curve from time 0 to the time of the last measured concentration (AUC(0–last)), the concentration-time curve from time 0 to infinity (AUC(0–∞)), time to maximum serum concentration (Tmax), and maximum serum concentration (Cmax). These measures were considered equivalent if 90% confidence intervals (CIs) of geometric mean ratios (GMRs) were within a predefined equivalence margin of 0.80 to 1.25.

Secondary outcomes included comparisons of pharmacodynamics (PD), immunogenicity, and safety.

Patient Characteristics

Of 306 eligible patients, 287 completed the study. AEs were the main reason for study discontinuation. Each cohort contained 102 patients.

Among the 306 enrolled participants, 93.8% were male, and all were Asian. Findings should be interpreted considering this homogenous population. A phase 3 trial is underway to assess the efficacy of ADL-018 within a larger sample.

Biosimilar vs Reference Omalizumab

PK parameters were comparable across cohorts; the GMRs and their 90% CIs for each parameter were between 0.80 and 1.25, illustrating PK equivalence between the biosimilar and reference omalizumab. In addition, each cohort had a median Tmax of approximately 4 days following dose administration, indicating consistent absorption.

PD parameters were also comparable across cohorts. After dose administration, total IgE serum concentration increased gradually, reaching the maximum level after approximately 27 to 41 days. Levels decreased to baseline at the end of the study.

Conversely, free IgE concentration dropped after dose administration and reached a minimum level within 1 day. Levels then gradually increased to baseline by the end of the study.

Each treatment had a similar safety profile. In the ADL-018, US-OMA, and EU-OMA cohorts, 13.7%, 24.5%, and 14.7% of patients experienced at least 1 AE, respectively. Most AEs were low in severity, and none of the patients who received ADL-018 experienced a serious AE.

Treatment-emergent AEs (TEAEs) were recorded in 5.9%, 4.9%, and 3.9%, respectively. TEAEs included gastritis, headache, vomiting, common cold, muscle spasm, and allergic contact dermatitis.

Implications for Managed Care

These findings illustrate the bio-similarity of ADL-018 to reference omalizumab, which suggests it may demonstrate potential clinical efficacy in future trials.

The manageable and comparable tolerability observed across all 3 cohorts indicates omalizumab as a safe therapeutic option.

The ongoing phase 3 trial may confirm the efficacy and safety of ADL-018 and take the drug another step toward FDA approval.

Reference

Soitawala S, Prajapati H, Mehta H, Singh PK. Pharmacokinetic and pharmacodynamic bio-similarity of ADL‐018 to innovator omalizumab: a randomized study in healthy adults. Clin Pharmacol Drug Dev. 2026;15(9):e70098. doi:10.1002/cpdd.70098.