Omalizumab Biosimilar Equivalent to Reference Drug in Children With Severe Allergic Asthma

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P043, anomalizumab biosimilar, was found to be equivalent to reference omalizumab in reducing exacerbations and managing asthma, with no significant differences in efficacy and safety parameters.¹

“Allergic asthma has a considerable burden on the quality of life. A significant portion of moderate-to-severe allergic asthma patients need omalizumab, an anti-immunoglobulin-E monoclonal antibody, as an add-on therapy... This life-challenging disorder requires affordable and effective treatment options, which justifies an equivalency clinical study for a new biosimilar of omalizumab compared to the originator brand,” lead investigator Mostafa Ghanei, MD, professor, Chemical Injuries Research Center, Systems Biology and Poisonings Institute, Baqiyatallah University of Medical Sciences, Tehran, Iran, and colleagues wrote.¹

Ghanei and colleagues analyzed data from 256participants with uncontrolled moderate-to-severe allergic asthma enrolled in a phase 3, randomized, multicenter, double-blind, 2-armed, parallel, equivalency clinical trial (NCT05813470). Participants were randomized to receive either P043 or omalizumab at doses ranging from 150 to 375 mg based on pre-treatment serum total IgE level (IU/mL) and body weight (kg) every 2 or 4 weeks for 28 weeks.¹

The investigators found that P043 cohort had a 0.150 exacerbation rate (95% CI, 0.079-0.220) and the omalizumab cohort had a 0.190 exacerbation rate (95% CI, 0.079-0.220; per-protocol). The least squares mean differences of predicted Forced Expiratory Volume in the First second (FEV1) were -2.51% (95% CI, -7.17-2.15; P = .29) pre-bronchodilator use and -3.87% (95% CI: -8.79-1.04; P = .12) post-bronchodilator use.¹

In the P043 group, mean Asthma Control Test (ACT) scores at screening were 10.62 (standard deviation [SD], 2.93) and 20.93 (SD, 4.26) at last visit. In the omalizumab group, mean ACT scores were 11.09 (SD, 2.75) at screening and 20.46 (SD, 5.11) at the last visit.¹

In terms of safety, Ghanei and colleagues found that the enrolled participants experienced a total of 288 adverse events (AEs). The most common AEs were dyspnea and headache. Between the omalizumab and P043 cohorts, there were no significant differences in the overall incidence of AEs (P = .62) and serious AEs (P = .07). There was no evidence of anti-drug antibodies.

“Since asthma is a chronic condition, ensuring an acceptable safety profile is imperative for any treatment,” Ghanei and colleagues concluded.¹ “The findings of this study suggest that P043 can be used as an omalizumab biosimilar as an add-on treatment for uncontrolled moderate-to-severe allergic asthma patients.”

Other recent research in asthma found that dupilumab treatment of children aged 6–11 years who have uncontrolled moderate-to-severe type 2 asthma led to diminished rates of exacerbation and lung function improvements for up to 2 years, according to new findings from the largest dose cohort within both the VOYAGE and EXCURSION studies for children.²

Dupilumab significantly reduced annualized exacerbation rates as well as improvement ppFEV1 among the 158 children who had been treated with the drug continuously for up to 2 years. There were comparable reductions in severe asthma exacerbations and ppFEV1 improvements that had been observed in the study among the 85 children initially given a placebo and then shifted to 200 mg of dupilumab every 2 weeks within the EXCURSION study.²

REFERENCES
1. Ghanei M, Ghalebaghi B, Sami R, et al. Efficacy and safety of a proposed omalizumab biosimilar compared to the reference product in the management of uncontrolled moderate-to-severe allergic asthma: a multicenter, phase III, randomized, double-blind, equivalency clinical trial. Front Immunol. 2024;15:1425906. doi:10.3389/fimmu.2024.1425906
2.Phipatanakul W, Vogelberg C, Bacharier LB, et al. Dupilumab 200 mg was efficacious in children (6–11 years) with moderate-to-severe asthma for up to 2 years: EXCURSION open-label extension study. Pediatr Pulmonol. 2024; 1-8. doi:10.1002/ppul.27167.