Celltrion announced on the 6th that it launched 'Omniclo' (active ingredient: omalizumab), a biosimilar (replica biologic) used to treat allergic conditions such as chronic spontaneous urticaria and asthma, in the United States on the 5th (local time).
According to Celltrion, Omniclo is the first product among the biosimilars of the blockbuster drug 'Xolair' to enter the U.S. market. In particular, upon launch, it was listed as a preferred drug in the commercial insurance formulary of 'Optum,' a major U.S. prescription benefit manager (PBM), laying the foundation to accelerate initial market entry.
Omniclo was launched in the U.S. at a wholesale acquisition cost (WAC) approximately 15% lower than that of the original product, and was developed in three dosage forms—75mg, 150mg, and 300mg—to meet diverse administration needs based on patient profiles and treatment settings. In March of last year, it received approval from the U.S. Food and Drug Administration (FDA) for all indications held by the original drug in the U.S., including asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and immunoglobulin E (IgE)-mediated food allergies. Additionally, it secured Interchangeability status, meaning that if requirements such as relevant state laws and insurance policies are met, it can be substituted for the original product at the pharmacy level, further enhancing accessibility for healthcare providers and patients.
Notably, Celltrion successfully secured the rebate foundation, considered a key gateway to prescription expansion in the U.S. biosimilar market, from the time of launch. Celltrion's U.S. subsidiary signed a formulary listing agreement with Optum, one of the top three PBMs in the country, which is evaluated as a step toward securing sellable channels.
A Celltrion official stated, "We plan to fully ramp up local marketing targeting healthcare providers, insurers, and distribution channels to drive actual prescription growth." The official added, "We are currently conducting listing negotiations with other major PBMs, some of which are in the final stages of contract signing. Once additional listings are completed, insurance coverage and patient accessibility within the U.S. will expand further."
Omniclo is rapidly establishing itself in Europe by translating first-mover advantages into actual market share. It is currently sold in 26 European countries, and in Spain, its market share surpassed 90% as of July this year (according to IQVIA). In Denmark, it is expected to record a market share level of 98% by the end of the year, based on winning national tenders.
Celltrion plans to replicate the growth formula of "early launch → securing market accessibility → prescription expansion" proven in Europe in the U.S. It is observed that Celltrion will immediately leverage its already established direct sales network and existing product sales and distribution networks for Omniclo in the U.S. Celltrion's U.S. subsidiary aims to rapidly expand the scope of PBM listings while utilizing prescription data accumulated during the prescribing process, as well as healthcare provider and patient preferences, to further refine market-specific sales strategies.
Kim Bon-joong, CEO of Celltrion's U.S. subsidiary, stated, "Omniclo possesses product competitiveness with three dosage forms, in addition to the first-mover effect of being the first omalizumab biosimilar in the U.S., full indications, and interchangeability." He added, "As it was listed as a preferred drug by a major PBM simultaneously with its launch, we have also secured the foundation for initial prescription expansion." He further noted, "By combining the first-mover growth experience proven in Europe with our U.S. direct sales network and swiftly finalizing additional PBM listings, we will cultivate Omniclo into a key growth product in the U.S."
in THEBIO
