Celltrion's Omliclo Demonstrates Equivalence to Original in 40-Week Clinical Trial

Global Phase 3 Follow-up Data Released: Efficacy and Safety Confirmed
Smooth Progress in Targeting the 6 Trillion KRW Global Market Including the US and Europe

Celltrion announced on the 18th that the results confirming therapeutic equivalence at week 40 of the global phase 3 clinical trial for its biosimilar "CT-P39" (product name Omliclo), used for asthma and urticaria, have been published in the international immunology journal "Clinical & Translational Allergy (CTA)".

CTA (Clinical & Translational Allergy) is the official journal of the European Academy of Allergy and Clinical Immunology, an international academic society, and primarily features clinical and translational research on topics related to diseases such as asthma, allergic skin conditions, and food allergies.

Omliclo is a biosimilar of the antibody biologic "Xolair" (ingredient name omalizumab), developed by global pharmaceutical companies Genentech and Novartis. As of last year, Xolair recorded global sales of approximately 6 trillion KRW.

The newly published study included results confirming efficacy and safety after 24 weeks of treatment and an additional 16-week follow-up period in 619 patients with chronic idiopathic urticaria. The study compared five groups: ▲CT-P39 300mg monotherapy group ▲Switch group from Xolair 300mg to CT-P39 300mg ▲Xolair 300mg monotherapy group ▲CT-P39 dose escalation group from 150mg to 300mg ▲Xolair dose escalation group from 150mg to 300mg. Similar trends were observed across all groups, supporting therapeutic equivalence.

Omliclo has been approved as the first Xolair biosimilar in major global markets, including Korea, the United States, the European Union (EC), the United Kingdom, and Canada. According to Celltrion, in the United States, it has been recognized as an "interchangeable" biosimilar, which is expected to allow pharmacies to substitute it for the original product without a change in the physician's prescription.

Celltrion plans to leverage this competitive edge to secure a leading position and accelerate its market strategy in the global omalizumab market. A company representative stated, "With Omliclo's global clinical results published in an international journal, we have once again demonstrated our product's competitiveness. As we have obtained first-mover approval in major countries, we will expedite the remaining commercialization procedures and launch the product as soon as possible to drive sales growth."