On 26 October 2026, Celltrion announced that its US subsidiary has signed an exclusive supply agreement with a major US healthcare company for its pre-filled syringe (PFS) formulation of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), and its intravenous and subcutaneous formulations of Avtozma® (CT-P47), biosimilar to Roche’s RoActemra® (tocilizumab). The unidentified US healthcare company owns various large hospitals, insurance companies and pharmacy benefit managers (PBMs) across the US.
Under the agreement, Omlyclo® and Avtozma® will be listed as the sole preferred products on the insurers’ formularies and supplied to affiliated medical institutions. Insured patients who receive a prescription of either product will be able to receive treatment under their insurance coverage. Product supply and insurance coverage began in October 2026.
Celltrion’s Omlyclo® was launched in the US in October 2026, following approval in March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and December 2025 (300mg formulation). Leveraging its first-mover advantage as the first omalizumab biosimilar launched in the US, Celltrion is expanding its supply channels for Omlyclo®. In October 2026, Celltrion signed a separate supply contract for Omlyclo® with a major global US distributor. Additionally, Celltrion is conducting formulary listing negotiations with multiple PBMs, with the contracts expected to finalise within Q4 of 2026.
Both intravenous and subcutaneous formulations of Avtozma® were first approved in the US in January 2025, with the IV formulation launched in October 2025. In December 2025, Celltrion secured reimbursement coverage for Avtozma® IV in the US, with patient reimbursement available from January 2026.