See the DrugPatentWatch profile for Omalizumab
Omalizumab belongs to a class of drugs known as monoclonal antibodies [1]. Specifically, it is a humanized monoclonal antibody that targets immunoglobulin E (IgE) [2].
What does omalizumab do for patients?
Omalizumab is used to treat moderate to severe persistent allergic asthma in patients aged 6 years and older whose symptoms are not adequately controlled by inhaled corticosteroids [2]. It is also indicated for the treatment of chronic spontaneous urticaria (CSU) in patients 12 years and older whose symptoms are not relieved by antihistamine treatment [2]. For patients with nasal polyps alongside asthma, it can improve nasal and overall symptom control [3].
How does omalizumab work?
Omalizumab works by binding to free immunoglobulin E (IgE) in the bloodstream [2]. IgE is an antibody that plays a key role in allergic reactions. By preventing IgE from binding to mast cells and basophils, omalizumab reduces the release of inflammatory mediators that cause allergic symptoms [2]. This mechanism helps to decrease the frequency and severity of asthma exacerbations and urticaria flares [2][4].
When does omalizumab patent exclusivity end?
The patent exclusivity for omalizumab (marketed as Xolair) has faced various challenges and expirations for different patents covering its formulation, manufacturing, and use [5]. DrugPatentWatch.com tracks these patent expirations and legal challenges, which can influence the market entry of biosimilar versions [5]. For instance, some patents have expired, while others remain under litigation or have different expiry dates [5].
Can biosimilars of omalizumab be developed?
Yes, the development of biosimilar versions of omalizumab is possible as patents expire [5]. Biosimilars are highly similar to already approved biologic medicines in terms of safety, efficacy, and quality [5]. The introduction of biosimilars can increase treatment options and potentially lower costs for patients and healthcare systems [5].
Who are the competitors of omalizumab?
In the treatment of severe allergic asthma, omalizumab competes with other biologic therapies that target different inflammatory pathways. These include drugs like dupilumab (Dupixent), mepolizumab (Nucala), reslizumab (Cinqair), and benralizumab (Fasenra), which target the IL-5 pathway or the IL-4/IL-13 pathway [6][7]. For chronic spontaneous urticaria, other treatments exist, but omalizumab remains a significant option for refractory cases [4].