[Kyoto (Japan) = E-Daily Reporter KIM SAE-MI ] “Unlike other biologics, which primarily target asthma exacerbations, omalizumab differs in that it focuses on symptom control.”

Even if asthma hasn’t significantly worsened, should one consider treatment with biologics if they suffer from coughing and shortness of breath every night? Yasuhiro Kon, a professor in the Department of Respiratory Medicine at Nihon University School of Medicine, highlighted the importance of managing daily symptoms in patients with severe allergic asthma.

At an educational seminar hosted by Celltrion during the World Allergy Congress (WAC 2026), held on the 16th at the Kyoto International Conference Center in Japan, Professor Gon explained treatment strategies for severe allergic asthma and emphasized “symptom control” as a distinguishing feature of omalizumab (the active ingredient in “Xolair”). The presentation was titled “Recent Advances in Immunoglobulin E (IgE)-Targeted Therapy for Severe Allergic Asthma.”

Professor Gon is scheduled to serve as the chair of the 76th Annual Meeting of the Japanese Society of Allergy, to be held in Tokyo next October. Professor Kimihiro Okubo of Nippon Medical School, who moderated the seminar, introduced Professor Gon and hinted, “Since he will be chairing next year’s conference, we will have another opportunity to hear from Professor Gon next year.”

“Beyond Preventing Asthma Exacerbations to Symptom Control”… The Distinctive Features of Omalizumab

Omalizumab is a therapeutic agent that targets immunoglobulin E (IgE), an antibody involved in allergic reactions. IgE is an antibody produced when the immune system recognizes specific substances, such as pollen or house dust mites, as allergens. Omalizumab binds to free IgE circulating in the blood to suppress allergic reactions, thereby improving asthma symptoms and reducing the risk of acute exacerbations.

Professor Gon emphasized that, unlike some other biologics, omalizumab focuses not only on preventing asthma exacerbations but also on managing day-to-day symptoms. In Japan, it is used for patients with severe allergic asthma whose symptoms are not adequately controlled by existing treatments, such as high-dose inhaled steroids.

The Japanese approval criteria specify that, for adults, reduced lung function, daily asthma symptoms, and nocturnal symptoms occurring at least once a week are used to determine eligibility for treatment. For children, daily asthma symptoms, nocturnal symptoms, and limitations in daily life are also taken into consideration.

Professor Gon stated, “While some biologics that have emerged since then primarily target asthma exacerbations, omalizumab differs in that it focuses on symptom control.” He added, “Although allergen-induced exacerbations are common in the spring, viral infections are the main cause in the winter,” noting that “omalizumab has also been shown to suppress asthma exacerbations associated with viral infections.”

“The Longer It Is Administered, the More It Suppresses IgE Production”… Attention on the Potential for Long-Term Treatment

Professor Gon noted, “Whether IgE levels are high or low, there may be little difference in efficacy for patients who meet the administration criteria,

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and remarked, “It is difficult to predict treatment response based solely on total IgE levels.”

After omalizumab administration, IgE bound to the drug remains in the blood for an extended period, which can actually cause total IgE levels to rise. In contrast, free IgE—which is involved in allergic reactions—decreases. Professor Gon explained that by examining both the degree of clinical symptom improvement and free IgE levels 16 weeks after administration, it is possible to assess the treatment response more precisely.

However, it is still not easy to measure free IgE separately in general clinical practice. Professor Gon said, “We are currently developing a free IgE testing method in collaboration with a company,” adding, “I hope we can present the results before next year’s academic conference. We are also working to secure insurance coverage.”

The possibility of suppressing IgE production through long-term administration was also raised. Simulations based on clinical trial data showed that the longer omalizumab is administered—for 1, 3, or 5 years—the lower the IgE production rate becomes, and the rate of recovery after discontinuation also slows down.

Professor Gon explained, “One of the benefits of long-term use of omalizumab is that continuous administration can suppress the body’s ability to produce IgE,” adding, “With continued use for 1, 3, or 5 years, the IgE production rate gradually decreases, and even after discontinuation, the subsequent recovery is gradual.”

“Giving Up Treatment Due to High Drug Costs”… Could Omliclo Be the Breakthrough?

As researchers evaluate treatment responses and examine the effects of long-term administration, biosimilars—which reduce the financial burden of drug costs—are emerging as new treatment options.

According to Professor Gon, there are many cases where patients who could benefit from omalizumab are unable to start treatment due to high drug costs. He noted, “Even when we propose biologics as a treatment option, many patients say they find it difficult to use them because of the cost,” expressing hope that the introduction of biosimilars will improve access to treatment.

Celltrion(068270)plans to launch “Omriclo” (CT-P39), a biosimilar of the original omalizumab-based drug “Xolair,” in Japan by the end of this year. In Japan, it has been approved for the treatment of bronchial asthma, seasonal allergic rhinitis, and chronic idiopathic urticaria. As a biosimilar, it is expected to be available at a price approximately 40% lower than the originator product.

Since omalizumab is a treatment that can be administered long-term depending on the patient’s condition, the cost of the medication is a key factor in deciding whether to continue treatment. Professor Gon is also interested in whether the price competitiveness of biosimilars will lead not only to existing patients switching medications but also to improved access for new patients who have not yet started treatment.

Professor Gon commented, “The newly introduced omalizumab biosimilar offers significant advantages in terms of cost-effectiveness,” adding, “I believe it will be an option to consider before other medications for suitable patients.”