Health Canada Approves Celltrion's Omlyclo, First Omalizumab Biosimilar
核心洞察
Health Canada has approved Omlyclo, Celltrion's biosimilar of omalizumab, for allergic asthma (搜索), chronic rhinosinusitis with nasal polyps (搜索), and chronic idiopathic urticaria (搜索).
The approval was based on a Phase III trial demonstrating bioequivalence to Xolair in efficacy, safety, pharmacokinetics, and immunogenicity in CSU patients.
Celltrion also received positive CHMP opinions for biosimilars of aflibercept, denosumab, and tocilizumab, expanding its biosimilar portfolio in Europe.
Health Canada has approved Omlyclo (CT-P39), Celltrion's biosimilar to omalizumab, marking the first such approval in Canada. This decision allows Omlyclo to be marketed for the treatment of allergic asthma (搜索), chronic rhinosinusitis with nasal polyps (搜索) (CRSwNP), and chronic idiopathic urticaria (搜索) (CIU), also known as chronic spontaneous urticaria (CSU), in adults and adolescents.
The approval is based on the results of a Phase III double-blind, randomized, active-controlled trial (NCT04426890) involving 619 patients with CSU across multiple countries. The study demonstrated that CT-P39 is bioequivalent to Xolair, the reference product, in terms of efficacy, safety, pharmacokinetics, and immunogenicity. The biosimilar met all pre-defined equivalence criteria.
Clinical Significance
Omalizumab, the active ingredient in both Xolair and Omlyclo, is an anti-immunoglobulin E (IgE (搜索)) antibody. It has been a primary treatment option for CIU and asthma for two decades. According to Elea Netchiporouk, MD, MSc, FRCPC, McGill University Health Centre, CIU significantly impacts patients' quality of life, affecting both physical and emotional well-being. The introduction of Omlyclo offers a potentially more accessible treatment option.
Celltrion's Expanding Biosimilar Portfolio
In addition to the Omlyclo approval in Canada, Celltrion announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions for three additional biosimilars: Eydenzelt (aflibercept biosimilar), Stoboclo/Osenvelt (denosumab biosimilars), and Avtozma (tocilizumab biosimilar).
- Eydenzelt (CT-P42, aflibercept biosimilar): Recommended for retinal disorders, including wet age-related macular degeneration (AMD) and diabetic macular edema (DME). A Phase III study confirmed its equivalence to Eylea.
- Stoboclo/Osenvelt (CT-P41, denosumab biosimilars): Recommended for all indications of Prolia and Xgeva, including osteoporosis. Phase III trials demonstrated equivalent efficacy, safety, and pharmacokinetics.
- Avtozma (CT-P47, tocilizumab biosimilar): Recommended for all indications of RoActemra, including rheumatoid arthritis and juvenile idiopathic arthritis. Data showed no clinically meaningful differences compared to the reference product.
Market Impact
Xolair, developed by Genentech and Novartis, generated approximately $3.7 billion in global sales in 2022. The Canadian market is estimated to be worth $138 million. Omlyclo's entry into the market is expected to provide a cost-effective alternative, potentially increasing access to treatment for a wider patient population.
Celltrion is also seeking approval for Omlyclo from the FDA, with a biologics license application accepted in March 2024. The company's advancements underscore its commitment to expanding the availability of biosimilar treatments globally.