Celltrion "Zolair Biosimilar 'CT-P39', Domestic Marketing Authorization Application Submitted"

Approval Application Completed Domestically Following Europe

Celltrion announced on the 30th that it has completed the application for marketing authorization of the biosimilar 'CT-P39' of Xolair (active ingredient omalizumab), a treatment for allergic asthma and chronic idiopathic urticaria, to the Ministry of Food and Drug Safety.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

Based on the global Phase 3 clinical trial results of CT-P39, Celltrion submitted the domestic marketing authorization application on the same day for the indications of allergic asthma and chronic idiopathic urticaria.

Prior to this domestic approval application, Celltrion completed the marketing authorization application for CT-P39 to the European Medicines Agency (EMA) in April. Additionally, it plans to sequentially apply for approval in major global countries including the United States. Leveraging its development speed advantage over competitors, Celltrion aims to accelerate the approval process to achieve a first-mover launch in key global markets.

Celltrion expects that once CT-P39 obtains domestic approval, it will expand its portfolio to various diseases including allergic diseases, following previously launched autoimmune and anticancer drugs, thereby securing competitiveness in the domestic market.

The original drug of CT-P39, Xolair, is an antibody biopharmaceutical developed by Genentech and Novartis, used for treating allergic asthma and chronic idiopathic urticaria. As of last year, it recorded global sales of approximately 5 trillion KRW and is a blockbuster product. The substance patent has already expired. The formulation patent is set to expire in March 2024 in Europe and November 2025 in the United States, respectively.

A Celltrion official stated, "We confirmed equivalence and similarity to the original drug in the global Phase 3 clinical trial of CT-P39 and have completed the approval application to the Ministry of Food and Drug Safety. We will do our best to submit the remaining applications and proceed with the procedures to enter the market as a first-mover in major countries including Europe, Korea, and the United States."

Celltrion plans to complete global approval applications for up to five biosimilar products, including CT-P39, by the end of this year.

This content was produced with the assistance of AI translation services.