THE PREVALENCE of asthma varies globally, ranging from 3.3% in Iran to 10.4% in the United States (IHME, 2019). For patients with moderate-to-severe asthma, biologic agents such as anti-interleukin (anti-IL) 5 or anti-immunoglobulin E (anti-IgE) drugs have emerged as effective add-on therapies. Omalizumab, an anti-IgE monoclonal antibody, reduces serum free IgE levels, thereby mitigating inflammatory responses in the bronchial and peripheral tissues. This mechanism of action leads to decreased levels of IL-2, IL-4, IL-5, and IL-13, which are key contributors to asthma inflammation.
According to the Global Initiative for Asthma (GINA), 17% of asthma patients fall into the difficult-to-treat category. Omalizumab is recommended as a first-line add-on therapy to inhaled corticosteroids (ICS) for stage 4 uncontrolled asthma, reducing annual exacerbation rates by approximately 38%. Additionally, omalizumab use is associated with a 43% lower need for systemic corticosteroid bursts and has shown potential in alleviating allergic rhinitis, a frequent comorbidity in asthma patients.
Given that 60% of asthma-related costs are attributed to severe, uncontrolled cases, the need for cost-effective treatment alternatives is crucial. This has led to the development of biosimilars such as P043, which aims to offer comparable efficacy to the reference drug, omalizumab. A clinical study evaluating P043 found no statistically significant differences in exacerbation rates between P043 and omalizumab over a 28-week period. Both groups demonstrated improvements in lung function and Asthma Control Test (ACT) scores, with a time-group interaction indicating a higher ACT score for omalizumab initially, which later aligned with P043.
Safety assessments revealed comparable adverse event (AE) profiles between P043 and omalizumab, with common AEs including injection site reactions, dyspnoea, and headaches. Severe adverse events (SAEs) were reported in 2.4% of the P043 group and 7.2% of the omalizumab group, without significant differences.
In conclusion, the findings support the equivalency of P043 to omalizumab in managing uncontrolled allergic asthma. With comparable efficacy and safety, P043 represents a viable biosimilar option, providing an alternative for patients requiring biologic therapy.
Katie Wright, EMJ
Reference
Ghanei M 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.
