Celltrion said on the 24th that it received additional approval from the Ministery of Food and Drug Safety for the auto-injector (AI) formulation of the allergy disease treatment "OMLYCLO."
The formulations approved this time are two types: 75 mg and 150 mg. By adding the AI formulation to the previously approved products, Celltrion has expanded OMLYCLO's formulation lineup.
Celltrion won domestic approval for OMLYCLO in June last year and, earlier this month, obtained approval for the 300 mg prefilled syringe (PFS) formulation. Including the AI formulation approval this time, OMLYCLO now has PFS formulations for all strengths—75 mg, 150 mg, and 300 mg—along with two AI formulations.
The company noted that AI formulations are often used for self-administration, which could improve treatment access for patients who have difficulty making frequent visits to medical institutions. It also said this could affect treatment convenience for patient groups that prefer self-injection.
OMLYCLO is a biosimilar with the Omalizumab ingredient and is used to treat allergy diseases such as chronic spontaneous urticaria and asthma. It has received approval in major markets, including Korea, the United States, and Europe, and is being launched sequentially.
The original drug "XOLAIR" recorded global sales of about 6.4992 trillion won last year.