Health Canada’s approval of Celltrion’s Omricleo marks the company’s latest push into North America’s biosimilar market. The treatment, which targets allergic asthma and chronic idiopathic urticaria, becomes the first biosimilar version of Novartis’s Xolair to secure Canadian regulatory clearance.
The South Korean drugmaker’s entry comes as Xolair posted global sales of 5 trillion won ($3.8 billion) last year, with the Canadian market valued at $138 million. Celltrion aims to leverage Canada’s favorable biosimilar policies to expand its presence.
The approval follows Phase 3 trials involving 619 patients with chronic idiopathic urticaria, where Omricleo demonstrated comparable safety and efficacy to Xolair. The regulatory green light covers multiple conditions, including chronic rhinosinusitis with nasal polyps.
Celltrion’s strategy focuses on challenging established biologics with cost-effective alternatives. The company sees Canada as a key market for building its North American footprint, citing the country’s adoption of policies supporting biosimilar medications.
The approval strengthens Celltrion’s Canadian portfolio just as Xolair received additional U.S. approval for food allergy treatment, potentially expanding the market opportunity for biosimilar competitors.
Company officials said they plan to enhance competitiveness while maintaining high-quality pharmaceutical supply in the Canadian market.
