Celltrion Launches Omniclo in the U.S., Listed in Major PBM Formulary

Listed as a Preferred Drug in a Major PBM’s Private Insurance Formulary

Celltrion has launched 'Omniclo' (active ingredient: omalizumab), a treatment for chronic spontaneous urticaria and allergic asthma, in the United States. As the first omalizumab biosimilar to enter the U.S. market, it secured an initial foundation for market expansion by being listed in the formulary of a major pharmacy benefit manager (PBM) upon release.

Product image of Celltrion's "Omliclo" (active ingredient omalizumab). Celltrion

On October 6, Celltrion announced that Omniclo has been introduced in the U.S. at a wholesale acquisition cost (WAC) approximately 15% lower than that of the reference product. It is being supplied in three dosage forms: 75mg, 150mg, and 300mg.

In March of last year, Omniclo received approval from the U.S. Food and Drug Administration (FDA) for all indications held by the original drug in the United States, including asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and IgE-mediated food allergy. The product also gained interchangeability status, allowing pharmacies to substitute it for the reference product if relevant legal and insurance requirements are met.

Notably, upon its launch, Omniclo was listed as a preferred drug in the private insurance formulary of one of the largest PBMs in the United States. Listing in PBM formularies is crucial for insurance reimbursement and patient access in the U.S. market. Celltrion is also negotiating with other major PBMs for formulary inclusion, with some agreements expected to be finalized soon.

Celltrion plans to replicate the early market penetration success of Omniclo observed in Europe within the United States. Currently, Omniclo is sold in 26 European countries and, as of July this year, had surpassed a 90% market share in Spain. In Denmark, based on success in national tenders, market share is expected to reach about 98% by the end of the year.

In the U.S., Celltrion will leverage its established direct sales network and sales and distribution channels to increase prescriptions. In August, Celltrion’s blood cancer treatment 'Truxima' recorded a 39% market share in the U.S., while the autoimmune disease treatment 'Inflectra' achieved 31%. 'Stekima' and 'Yuflyma' also posted market shares of 15% and 12%, respectively.

Bonjoong Kim, CEO of Celltrion USA, stated, "Omniclo has the advantage of being the first omalizumab biosimilar in the United States, in addition to having all indications, interchangeability status, and three dosage forms to enhance product competitiveness. We will expedite additional PBM formulary inclusions to establish Omniclo as a leading growth product in the U.S. market."

This content was produced with the assistance of AI translation services.