Celltrion has launched its chronic spontaneous urticaria and allergic asthma treatment, Omliclo (generic name: omalizumab), in the United States. This marks the first entry of an omalizumab biosimilar into the U.S. market, and it has been included in the prescription drug lists of major pharmacy benefit managers (PBMs), establishing a foundation for initial market expansion.
On October 6, Celltrion announced that Omliclo is being offered at a wholesale acquisition cost (WAC) approximately 15% lower than that of the original drug. It is available in three dosage forms: 75 mg, 150 mg, and 300 mg.
Omliclo received approval from the U.S. Food and Drug Administration (FDA) in March of last year for all indications held by the original drug, including asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and IgE-mediated food allergies. It has also secured interchangeability status, allowing it to replace the original drug at the pharmacy level if it meets relevant state laws and insurance policy requirements.
Notably, upon its launch, Omliclo was listed as a preferred drug in the private insurance formulary of Optum, a major U.S. PBM. Inclusion in PBM formularies is a critical factor that influences insurance reimbursement and patient access in the U.S. market. Celltrion is currently negotiating listings with other major PBMs, with some contracts nearing completion.
Celltrion plans to replicate the initial market penetration success of Omliclo in Europe in the U.S. The drug is currently sold in 26 European countries, and as of July this year, it has surpassed a 90% market share in Spain. In Denmark, it is expected to achieve a market share of around 98% by the end of the year, based on national tender wins.
In the U.S., Celltrion will leverage its established direct sales network and distribution channels to expand prescriptions. The company’s blood cancer treatment, Truxima, recorded a 39% market share in the U.S. in August, while its autoimmune disease treatment, Inflectra, held a 31% share. Stekima and Uplima also recorded shares of 15% and 12%, respectively.
Kim Bon-jung, CEO of Celltrion's U.S. subsidiary, stated, "Omliclo not only benefits from being the first omalizumab biosimilar in the U.S. but also possesses competitive advantages with its full range of indications, interchangeability, and three dosage forms. We aim to finalize additional PBM listings quickly to develop Omliclo into a key growth product in the U.S."
Meanwhile, Celltrion has been actively enhancing shareholder value this year, announcing a share buyback worth 400 billion won and a share cancellation worth 200 billion won. This aggressive execution aligns with the management's commitment to return one-third (approximately 33%) of annual consolidated net income to shareholders.
This strategy is supported by record-high performance and strong free cash flow. Last year, Celltrion achieved its highest-ever revenue of 4.1625 trillion won and an operating profit of 1.1685 trillion won. In the first half of this year, the company continued its high growth, recording revenue of 2.5387 trillion won and an operating profit of 773.7 billion won.
* This article has been translated by AI.
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