Celltrion announced on the 25th that it has received a recommendation for marketing authorization approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for CT-P39, a biosimilar of Xolair used to treat asthma and urticaria.
Xolair, the original drug of CT-P39, recorded global sales of approximately $3.9 billion (about 5 trillion KRW) last year, making it a blockbuster product. It is a blockbuster antibody biopharmaceutical used for allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. Recently, it also received approval for the indication of food allergy, raising expectations that the market size for this treatment will expand further. The substance patent has already expired, and the formulation patent is set to expire this month in Europe and in November next year in the United States.
This approval recommendation from Celltrion covers all indications held by Xolair. The CHMP discusses whether to approve a drug based on scientific evaluation results and provides its opinion to the EMA. Since the CHMP’s approval recommendation plays a decisive role in the final approval of medicines by the European Commission (EC), the recommendation is effectively interpreted as approval of the medicine in Europe.
Celltrion expects to receive the EC’s final approval as early as May. If approved, it is anticipated to become the first 'first mover' product among Xolair biosimilars authorized in Europe. After approval, the company plans to commercialize the product promptly and launch it in the market. CT-P39 has also applied for approval in South Korea, the United States, and Canada, in addition to Europe.
A Celltrion representative stated, "Once CT-P39’s European approval is completed, we will be able to enter the market as a first mover and rapidly expand market share based on the preemptive advantage. With multiple global approvals and launches scheduled this year beyond CT-P39, we will accelerate our global market dominance and sales growth through the introduction of new products."
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