Celltrion's First Zolair Biosimilar 'Omliclo' Also Approved in Korea

Allergic Asthma and Urticaria Treatment

Celltrion announced on the 25th that Omniclo (development name CT-P39), a biosimilar developed for Xolair, an allergic asthma and urticaria treatment, received approval from the Korean Ministry of Food and Drug Safety on the 24th.

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

The original drug Xolair, which Omniclo is a biosimilar of, recorded global sales of $3.9 billion (approximately 5.4132 trillion KRW) last year, making it a blockbuster antibody biopharmaceutical. It is used for allergic asthma and chronic spontaneous urticaria. Recently, it also received approval overseas for food allergy indications, raising expectations that the market size for this treatment will expand further.

This approval in Korea is the second major regional approval following the European approval last month. By being the first biosimilar of Xolair approved in both Europe and Korea, it has secured the position of 'first mover.' Applications for approval have also been submitted in other major countries such as the United States and Canada.

Celltrion previously demonstrated the efficacy and equivalence of Omniclo compared to the original drug in a Phase 3 clinical trial involving 619 patients with chronic spontaneous urticaria across six European countries, and confirmed similarity in safety as well. Based on this, the company applied for product approval from the Korean Ministry of Food and Drug Safety in June last year and received approval after about a year.

A Celltrion representative stated, “Omniclo is the first approved first-mover product in Europe and Korea, and we will rapidly expand market share based on the first-mover advantage in major countries. Since we can now provide a new treatment option to many patients suffering from allergic diseases not only in Europe but also domestically, we will do our best to supply the product and expand market share.”