Celltrion secures Canada's approval for Xolair biosimilar Omlyclo

(Celltrion)

South Korean biopharmaceutical firm Celltrion said Monday that it has received approval from Health Canada for Omlyclo, its omalizumab biosimilar referencing Xolair, designed to treat allergic asthma and chronic spontaneous urticaria.

Celltrion has obtained approval for the full range of indications covered by the original drug, including allergic asthma, chronic rhinosinusitis with nasal polyps and chronic idiopathic urticaria. The company supported its application with a global phase 3 clinical trial of CT-P39, involving 619 patients with chronic spontaneous urticaria. The study demonstrated the biosimilar’s efficacy, safety and equivalence to the reference drug, the company said.

Celltrion highlighted its position as a “first mover” in the biosimilar market, noting that Omlyclo was the first Xolair biosimilar to gain approval in the UK, Europe and South Korea earlier this year. Xolair, an antibody-based biomedicine, achieved global sales of approximately 5 trillion won ($3.5 billion) last year, including 179.4 billion won in Canada. With its latest approval in Canada, Celltrion aims to solidify its competitive edge in the biosimilar industry.

“With Health Canada’s approval of Omlyclo, we have enhanced our product portfolio and bolstered our market presence,” said a company official. “Given Canada's biosimilar-friendly policies, we plan to establish our position in the market with high-quality medicines.”

By Park Min-ha(en23mp@heraldcorp.com)