Omriclo Approved in Canada: Celltrion’s 300mg Formulation

SEOUL, January 29, 2024 — Celltrion has received additional approval from Health Canada for high-dose formulations of its omalizumab biosimilar, Omriclo, potentially easing the treatment burden for patients with chronic idiopathic urticaria. The newly approved 300mg prefilled syringe and autoinjector options deliver a sufficient drug amount in a single dose, reducing the frequency of administrations.

Biosimilar Omriclo Gains Full Canadian Approval, Targeting North American Expansion

Celltrion secures a complete lineup of omalizumab biosimilar formulations in Canada, bolstering its competitive edge in the North American market.

• Omriclo, a biosimilar to Xolair, now has full PFS and AI formulation approval (75mg, 150mg, 300mg) in Canada.
• This is the first time a full dosage composition of PFS and AI formulations has been achieved among omalizumab biosimilars globally.
• The high-dose formulation aims to reduce the number of administrations needed, improving patient convenience.
• Canada’s supportive biosimilar policies create a favorable environment for Omriclo’s market expansion.

Omriclo demonstrated comparable efficacy and safety to the original drug through a global phase 3 clinical trial involving 619 patients with chronic idiopathic urticaria. This approval solidifies Celltrion’s “first mover” status and strengthens its product competitiveness through formulation diversity.

What makes Omriclo different? This omalizumab biosimilar treats allergic conditions like chronic idiopathic urticaria and asthma and is currently available in Korea, the United States, Europe, and now with a complete formulation range in Canada. The original drug, Xolair, generated approximately KRW 6.4992 trillion in global sales as of 2024.

Did you know? Canada actively promotes biosimilar prescriptions through government policies, creating a receptive market for cost-effective alternatives.

Celltrion plans to capitalize on Canada’s biosimilar-friendly environment to expand its presence in the North American market. A Celltrion official stated, “By obtaining additional approval for the Omriclo 300㎎ PFS·AI formulation, we are now able to provide new treatment options to Canadian patients. We will do our best to expand the North American market, focusing on Canada, based on our product competitiveness as we have secured a full lineup of PFS·AI formulations in the market and have now been able to provide customized prescriptions for each patient.”

The new formulations offer medical staff expanded administration efficiency and a wider range of prescription options, potentially streamlining treatment for patients with chronic idiopathic urticaria.