Celltrion announced on the 9th that Omniclo (development name CT-P39), developed as a biosimilar of Xolair, a treatment for allergic asthma and chronic spontaneous urticaria, has received marketing authorization approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA). This approval was granted for the indications of allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria.
The original drug of Omniclo, Xolair, recorded global sales of $3.9 billion (approximately 5.4 trillion KRW) last year, making it a blockbuster antibody biopharmaceutical. It is used for allergic asthma, chronic spontaneous urticaria, and other conditions. Recently, it also received approval for food allergy indications overseas, raising expectations that the market size for this treatment will expand further.
Celltrion conducted a global Phase 3 clinical trial of Omniclo involving 619 patients with chronic spontaneous urticaria across six European countries, demonstrating efficacy and equivalence compared to the original drug and confirming similarity in safety. Based on this, Celltrion succeeded in obtaining the first approval for a Xolair biosimilar in Europe in May and in Korea in June, securing the position of a ‘first mover.’ With this approval, Omniclo has also secured first-mover status in the UK, and applications for approval have been submitted in other major countries such as the United States and Canada.
A Celltrion official stated, “Omniclo is the first Xolair biosimilar approved in the UK, and we plan to rapidly capture the market based on this first-mover advantage,” adding, “It is highly meaningful that we are able to provide a new treatment option to patients suffering from allergic diseases in the UK.”
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