Celltrion's Omriklo Approved as the First Biosimilar of Asthma Drug Xolair

Celltrion announced on the 24th that Omniclo (development name CT-P39), developed as a biosimilar of Xolair, which is used as a treatment for asthma and urticaria, has been approved as the first biosimilar in Europe.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

The original drug Xolair, on which Omniclo is based, recorded global sales of $3.9 billion (approximately 5 trillion KRW) last year, making it a blockbuster antibody biopharmaceutical. It is used for allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. Recently, it also received approval for the indication of food allergies, raising expectations that the market size for this treatment will further expand.

Omniclo received formal marketing authorization from the European Union (EU) Commission just over two months after receiving a ‘positive opinion’ from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in March. With this, Omniclo has secured the position of the first approved Xolair biosimilar in Europe as a first mover. Currently, approval applications have also been submitted in South Korea, the United States, and Canada, in addition to Europe.

Celltrion previously demonstrated the efficacy equivalence and safety similarity of Omniclo compared to the original drug in a Phase 3 clinical trial involving 619 patients with chronic spontaneous urticaria conducted in six European countries.

A Celltrion official stated, "With Celltrion’s major products already securing a high market share in Europe, we expect Omniclo to fully enjoy the benefits of being the first approved Xolair biosimilar as a first mover. Given the significant gap with latecomer competitors, we will rapidly expand market share based on the preemptive advantage while doing our best to supply patients with opportunities for high-quality treatment at reasonable prices." Currently, besides Celltrion, other Xolair biosimilars under development include Teva’s TEV-45779, which recently completed Phase 3 trials, and Kashiv Bioscience-Alvotech’s ADL018, which is undergoing Phase 3 trials.