Celltrion Secures Additional Domestic Approval for OMLYCLO AI Formulation

Enhanced Administration Efficiency and Patient Convenience

Celltrion announced on December 24 that it has received additional approval from the Ministry of Food and Drug Safety for the autoinjector (AI) formulation of 'OMLYCLO' (ingredient: omalizumab), a treatment for chronic spontaneous urticaria.

With the acquisition of two AI formulations of OMLYCLO-75mg and 150mg-Celltrion has significantly enhanced treatment convenience by expanding self-injection options for patients. Notably, the AI formulation is not available in the original product in Korea, giving OMLYCLO a broader range of formulations compared to the original.

Since obtaining domestic approval for OMLYCLO as a 'First Mover' in June last year, Celltrion has secured the 300mg pre-filled syringe (PFS) formulation, which was approved earlier this month, and now the AI formulation as well. As a result, OMLYCLO now offers a full lineup of PFS dosages (75mg, 150mg, 300mg) and two AI formulations.

Celltrion expects that the high preference for AI formulations in self-administration will improve treatment accessibility for patients who find frequent hospital visits difficult, and also enhance treatment satisfaction among patients who prefer self-injection.

OMLYCLO is an omalizumab biosimilar used to treat various allergic diseases, including chronic spontaneous urticaria and asthma. It has been sequentially launched as a 'First Mover' in major global markets, including Korea, the United States, and Europe, following regulatory approvals. The original drug, Xolair, recorded global sales of approximately 6.4992 trillion won last year.

A Celltrion representative stated, "With this approval for the OMLYCLO AI formulation, we can now offer a self-injection option not available in the original product in Korea. By adding the AI formulation to our full range of PFS dosages, we have completed an extensive lineup of formulations. We will do our utmost to expand our global market share based on this strengthened product competitiveness."