Celltrion announced today that Health Canada has approved Omlyclo™, a biosimilar referencing Xolair®. Omlyclo™ is now approved for the treatment of adults and adolescents with chronic idiopathic urticaria (CIU), also known as chronic spontaneous urticaria (CSU), as well as for adult and pediatric patients with allergic asthma and adults with chronic rhinosinusitis with nasal polyps (CRSwNP).
Celltrion announced that Health Canada has approved Omlyclo™, the first biosimilar referencing Xolair® (omalizumab), for the treatment of chronic idiopathic urticaria (CIU), allergic asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP). Omlyclo™ is now authorized for use in both adult and adolescent patients with CIU (also known as chronic spontaneous urticaria or CSU), as well as in pediatric and adult patients with allergic asthma, and adults with CRSwNP.
“Diseases like CIU significantly impact patients’ quality of life, both physically and emotionally. Omalizumab has been the only anti-IgE antibody approved for CIU and asthma over the past two decades, but there is still a need for more diverse treatment options for allergic diseases,” said Dr. Elena Netchiporouk, MD, M.Sc., FRCPC, assistant professor at the Department of Medicine, Division of Dermatology, MUHC. “I am pleased that Omlyclo is now approved as the first omalizumab biosimilar in Canada, providing new treatment options for patients suffering from these conditions.”
The approval of Omlyclo™ is based on comprehensive clinical data, including results from a global Phase III clinical trial. The trial evaluated Omlyclo’s efficacy, safety, pharmacokinetics, and pharmacodynamics compared to the reference product in patients with chronic idiopathic urticaria (CIU). The trial results demonstrated therapeutic equivalence between Omlyclo and the reference omalizumab, supporting its approval for use in Canada.
“Today’s approval reaffirms our commitment to delivering affordable, high-quality biologic therapies for individuals in Canada with immunological conditions like asthma,” said Jungyong Shin, Managing Director at Celltrion Healthcare Canada. “Leveraging our experience and track record in immunology and oncology, we are excited to bring innovative treatments to meet the critical unmet needs of patients in Canada.”
About Omlyclo™
Omlyclo™ is the first Health Canada-approved anti-IgE antibody biosimilar referencing Xolair® (omalizumab). It is indicated for the treatment of chronic idiopathic urticaria (CIU) or chronic spontaneous urticaria (CSU) in adults and adolescents (12 years and older), allergic asthma in both adult and pediatric patients (6 years and older), and chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. Omlyclo is administered as subcutaneous injections in two strengths: 75 mg/0.5 mL and 150 mg/1.0 mL.
About Celltrion
Celltrion is a leading biopharmaceutical company headquartered in Incheon, South Korea, specializing in the research, development, manufacturing, and marketing of innovative therapeutics that improve people’s lives worldwide. With a strong commitment to offering high-quality, cost-effective treatments, Celltrion has expanded its global presence to over 110 countries. The approval of Omlyclo™ marks Celltrion’s fifth biosimilar approved by Health Canada, following Remsima™ SC (infliximab), Yuflyma® (adalimumab), Vegzelma® (bevacizumab), and SteQeyma® (ustekinumab).