Celltrion said on the 29th that it obtained additional approval from Health Canada for the 300 mg prefilled syringe (PFS) and 300 mg autoinjector (AI) formulations of the chronic spontaneous urticaria treatment "OMLYCLO" (ingredient Omalizumab).
The 300 mg PFS and AI formulations are high-dose products that can deliver a sufficient amount of medication with a single administration, reducing the number of doses.
With this approval, Celltrion has secured the full lineup of PFS and AI formulations (75 mg, 150 mg, 300 mg) held by the original drug in Canada.
This is the first case among Omalizumab biosimilars to complete the full range of PFS and AI formulations. The company is sequentially launching after obtaining first-mover approvals in major global markets, including the United States, Europe, Canada, and Korea. XOLAIR, the original drug of OMLYCLO, recorded global sales of about 6.4992 trillion won in 2024.
A Celltrion official said, "With the additional approval of the OMLYCLO 300 mg PFS and AI formulations, we can offer a new treatment option to patients in Canada," and added, "We will do our best to expand into the North American market centered on Canada based on the product's competitiveness."