Celltrion Receives UK Approval for Asthma Drug Biosimilar 'Xolair'
First Product in the UK Market... Anticipating a First-Mover Advantage
Celltrion has announced that their biosimilar Omvoh (CT-P39), a treatment for allergic asthma and chronic idiopathic urticaria, has been approved by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
This marks the first approval of a Xolair biosimilar in the UK, positioning Celltrion as a market leader. The approval includes indications for allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria.
Celltrion conducted a global Phase 3 trial with 619 chronic idiopathic urticaria patients across six European countries, demonstrating the efficacy and safety equivalence of CT-P39 compared to the original drug.
Following approvals in Europe in May and Korea in June, this latest approval reinforces Celltrion's first-mover status in the UK market.
The original drug, Xolair, is an antibody biopharmaceutical used to treat allergic asthma and chronic idiopathic urticaria, with global sales of approximately $5 billion last year. The UK market was estimated at $67 million (about 87.1 billion KRW) in the same period.
A Celltrion representative stated, "Leveraging our first-mover advantage in the UK, we aim to rapidly penetrate the market, providing new treatment options for patients suffering from allergic diseases."