Celltrion Launches Omryklo in the US, Expanding Allergy Treatment Portfolio

Celltrion has officially introduced Omryklo, its new biosimilar treatment, in the United States. This product targets chronic spontaneous urticaria and allergic asthma, expanding the company's portfolio in the allergy treatment sector.

Omryklo is noted for being the first omalizumab biosimilar to enter the U.S. market, offering a wholesale acquisition cost approximately 15% lower than the original product. It is available in three dosage forms: 75 mg, 150 mg, and 300 mg, catering to various patient needs.

The U.S. Food and Drug Administration (FDA) approved Omryklo in March 2025 for multiple indications, including asthma and IgE-mediated food allergies. Notably, it carries interchangeability status, allowing pharmacists to substitute it for the original drug without needing a new prescription.

At launch, Omryklo was included as a preferred drug on Optum's commercial formulary, a significant step for biopharmaceutical distribution in the U.S. market. Celltrion is currently negotiating with other major pharmacy benefit managers for additional listings.

Kim Bon-joong, CEO of Celltrion USA, emphasized the product's competitiveness and the company's strategy to leverage its European success in the U.S. market. The launch of Omryklo marks a significant milestone for Celltrion as it diversifies its offerings into the allergy treatment space.