Improved Administration Efficiency and Patient Convenience
Celltrion announced on December 3 that it has received additional approval from the U.S. Food and Drug Administration (FDA) for the 300mg pre-filled syringe (PFS) formulation of Omliclo (ingredient: omalizumab), a treatment for chronic spontaneous urticaria.
With this approval, Omliclo now offers all three PFS dosage forms (75mg, 150mg, 300mg), identical to the original drug, enabling full-scale personalized dosing for patients. In particular, the newly approved high-dose 300mg PFS formulation can deliver a larger amount of medication in a single administration, significantly improving treatment convenience for patients who previously required multiple doses of the lower-dose products. This is expected to reduce the psychological burden of dosing and broaden prescription options.
Following its approval in Europe earlier last month, Celltrion has now secured authorization for the 300mg PFS formulation in the United States as well. As a result, Celltrion is the only biosimilar supplier to offer the full lineup of PFS dosage forms identical to the original drug in both the United States and Europe, which together account for approximately 89% of the global omalizumab market.
Having established a 'first-mover' position for Omliclo in major global markets, Celltrion expects to secure market leadership at a faster pace now that it alone offers the complete PFS product lineup matching the original drug's dosage forms. Notably, among competing follow-on products in the U.S. and European markets, no other supplier has secured the full range of PFS formulations to date, further strengthening Celltrion's early-mover advantage.
Omliclo became the first biosimilar to Xolair to receive market authorization in Europe in May last year and in the United States in March this year. Since then, it has been launched in major countries including Europe (EC), Australia, and Brazil, marking the start of a full-scale global market expansion. In Europe, in particular, Omliclo recorded cumulative sales of approximately 47 billion KRW through the third quarter, leveraging its direct sales competitiveness.
The original drug, Xolair, for which Omliclo is a biosimilar, is used to treat chronic spontaneous urticaria and asthma, and posted global sales of approximately 6.4992 trillion KRW last year.
A Celltrion representative stated, "With the additional approval of the 300mg PFS formulation of Omliclo, we can now offer a new treatment option to patients in the United States. Having secured the full lineup of PFS products in the market enables us to provide tailored prescriptions for a variety of patient cases, and we will do our utmost to expand our global market share based on the product's competitiveness."
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