Celltrion has announced that Health Canada has approved Omlyclo™, the first and only biosimilar referencing Xolair® (omalizumab) in Canada. Omlyclo™ is now authorized for the treatment of adults and adolescents with chronic idiopathic urticaria (CIU), also known as chronic spontaneous urticaria (CSU), adult and pediatric patients with allergic asthma, and adults with chronic rhinosinusitis with nasal polyps (CRSwNP).
“Diseases such as CIU have substantial detrimental effects on the quality of life for patients, often impacting both their physical and emotional well-being. Over the last two decades, omalizumab has been the only anti-IgE antibody approved for chronic idiopathic urticaria (CIU) and asthma. However, there remains an unmet medical need for a broader array of therapeutic options for allergic diseases,” stated Dr. Elena Netchiporouk, MD, M.Sc., FRCPC, assistant professor in the Department of Medicine, Division of Dermatology, at MUHC. “I am pleased that Omlyclo is now approved as the first omalizumab biosimilar in Canada, offering a new, cost-effective option for patients.”
The approval of Omlyclo by Health Canada is supported by robust clinical evidence, including data from a global Phase III clinical trial. This trial was designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Omlyclo compared to its reference product in patients with chronic idiopathic urticaria (CIU) over 40 weeks. The results demonstrated therapeutic equivalence between Omlyclo and the reference omalizumab, confirming its effectiveness and safety.
“Today’s approval reaffirms our commitment to providing affordable, high-quality biologic medicines to individuals living with immunological conditions such as asthma in Canada,” commented Jungyong Shin, Managing Director at Celltrion Healthcare Canada. “Leveraging our proven expertise and successful track record in immunology and oncology, we are poised to drive innovation in the fields of respiratory and allergy care, addressing the critical unmet needs of patients in Canada.”
The introduction of Omlyclo represents a significant advancement for Canadian patients managing chronic conditions such as CIU, allergic asthma, and CRSwNP. Chronic idiopathic urticaria is a debilitating condition characterized by recurrent, itchy hives lasting for six weeks or longer without an identifiable cause. Similarly, allergic asthma and chronic rhinosinusitis with nasal polyps are conditions that severely impact patients’ quality of life and require effective, long-term treatment options.
Omlyclo’s availability in Canada provides a cost-effective alternative to the reference product, addressing the growing demand for accessible biologic therapies. Biosimilars like Omlyclo are designed to match their reference biologics in terms of quality, efficacy, and safety while offering potential cost savings for healthcare systems and patients.
The global Phase III clinical trial that supported Health Canada’s approval included a diverse population of patients with CIU. The study’s findings confirmed that Omlyclo matched the reference product in therapeutic performance, delivering significant symptom relief while maintaining a favorable safety profile. These results underscore the potential of Omlyclo to provide a high-quality treatment alternative for Canadians living with challenging immunological conditions.
Celltrion’s Managing Director, Jungyong Shin, emphasized the company’s dedication to improving patient outcomes, stating, “With Omlyclo’s approval, we are taking another important step in expanding access to biosimilar therapies for Canadians. Our goal is to enhance affordability and availability while maintaining the highest standards of quality and innovation.”
Omlyclo’s launch aligns with global trends in healthcare to integrate biosimilars as a vital component of therapeutic regimens. By offering a cost-efficient option that does not compromise on quality, Omlyclo positions itself as a key player in advancing treatment for patients with chronic and allergic conditions in Canada.
With this milestone, Celltrion continues to strengthen its presence in the Canadian market and reinforce its commitment to addressing unmet medical needs. As the first omalizumab biosimilar approved in Canada, Omlyclo not only broadens treatment options but also sets a precedent for future innovations in biosimilar therapies. Patients and healthcare providers alike can now benefit from this important addition to Canada’s arsenal of therapeutic tools for managing chronic and allergic diseases.
