Health Canada approves Celltrion’s Omlyclo™ (CT-P39), the first and only omalizumab biosimilar in Canada

• Omlyclo™ (CT-P39) is the first and only omalizumab biosimilar referencing Xolair^® approved in Canada to treat multiple allergic diseases including chronic idiopathic urticaria (CIU), allergic asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP)¹
• Celltrion expands biosimilar portfolio to address allergic and respiratory diseases, enhancing access to innovative treatments in Canada

TORONTO--(BUSINESS WIRE)--Celltrion today announced that Health Canada has approved Omlyclo^™, a biosimilar referencing Xolair^®. Omlyclo^™ is approved for the treatment of adults and adolescents with chronic idiopathic urticaria (CIU), also called chronic spontaneous urticaria (CSU), adult and pediatric patients with allergic asthma, and adults with chronic rhinosinusitis with nasal polyps (CRSwNP).¹

“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 that has been approved for chronic idiopathic urticaria (CIU) and asthma, and there still remains an unmet medical need for a diverse array of allergic diseases,” said Dr. Elena Netchiporouk, MD, M.Sc., FRCPC, assistant professor of department of Medicine, division of Dermatology, MUHC. “I am pleased that Omlyclo is now approved as the first omalizumab biosimilar in Canada.”

Health Canada approved Omlyclo based on robust clinical evidence, including results from a global Phase III clinical trial designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Omlyclo compared to the reference product in patients with chronic idiopathic urticaria (CIU) up to Week 40. The results demonstrated the therapeutic equivalence between Omlyclo and reference omalizumab.²

“Today’s approval reaffirms our commitment to providing affordable, high-quality biologic medicines to individuals living with immunological conditions such as asthma in Canada,” said 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, meeting the critical unmet needs of patients in Canada.”

Notes to Editors:

About Omlyclo™

Omlyclo^™ is the first Health Canada approved anti-IgE antibody biosimilar referencing Xolair^® (omalizumab). In Canada, Omlyclo is indicated for the treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria (CIU) or chronic spontaneous urticaria (CSU), adult and pediatric patients (6 years of age and above) with allergic asthma, and adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Omlyclo is available as subcutaneous injections in two strengths: 75 mg/0.5 mL and 150 mg/1.0 mL.¹

About Celltrion

Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 countries. With the approval of Omlyclo^™, Celltrion now has five biosimilars approved by Health Canada: Remsima™ SC (infliximab), Yuflyma^® (adalimumab), Vegzelma^® (bevacizumab), SteQeyma^® (ustekinumab) and Omlyclo^™ (omalizumab). For more information, please visit: https://www.celltrionhealthcare.ca

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¹Omlyclo Product Monograph. Celltrion Inc. December 2024. Product information from Health Canada.
² Sarbjit S. Saini et al. CT-P39 compared to Reference Omalizumab in Patients with Chronic Spontaneous Urticaria; 40-Week Results. Annals of Allergy, Asthma & Immunology. Available at: https://www.annallergy.org/article/S1081-1206(24)00595-7/fulltext [Last Accessed December 2024].

Omlyclo™ is a trademark of Celltrion, Inc. and is used under license.
Xolair^® is a registered trademark of NOVARTIS AG.