Celltrion Announces Commercial Availability of Omlyclo™ Across Europe at EADV 2025
- Celltrion’s Omlyclo™, the first and only omalizumab biosimilar in Europe, will be commercially available starting in Norway, with subsequent rollouts in European countries
- Results from the global Phase III clinical trial of Omlyclo™ (CT-P39) for the treatment of chronic spontaneous urticaria (CSU), allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) will be presented at a satellite symposium during the 2025 European Academy of Dermatology and Venereology (EADV) Congress
- Celltrion highlights the strength of its expanding dermatology portfolio with positive clinical results for CT-P55, a biosimilar candidate referencing secukinumab
- With the launch of Omlyclo™, Celltrion underscores its commitment to advancing innovative and accessible treatments in immunology and dermatology
Celltrion, Inc. today showcased its longstanding commitment to expanding its biosimilar portfolio in the field of immuno-dermatology by attending the 2025 European Academy of Dermatology and Venereology (EADV) Congress, held 17-20 September in Paris, France. Following the European Commission (EC) approval of Omlyclo™, the first and only omalizumab biosimilar in Europe in May 2024, Omlyclo™ will be commercially available starting in Norway, with subsequent rollouts in European countries.
As part of Celltrion’s mission to advance knowledge and understanding in dermatology, especially in chronic spontaneous urticaria (CSU), the company hosted satellite symposium presenting the results of the global Phase III clinical trial of Omlyclo™. The global Phase III clinical trial involved 619 patients with CSU, following them up to week 40. Patients were randomized to receive 300 mg or 150 mg of Omlyclo™, or reference product, every 4 weeks. Starting from week 12, patients who received Omlyclo™ were continued on the same treatment and patients who initially received 300mg of the reference product were re-randomized in a 1:1 ratio to either switch to Omlyclo™ or to continue receiving the reference product. From week 24 until week 40, patients were observed without dosing. The results demonstrated that Omlyclo™ had comparable efficacy and safety to reference product during both treatment and off-dose periods.1,2
“Immuno-dermatology diseases such as CSU significantly impact a patient’s quality of life (QoL), affecting various aspects including mental and emotional well-being, social life, daily activities, and even financial stability,” said Prof. Martin Metz, MD, Deputy Director of the Institute of Allergology, Charité- Universitätsmedizin Berlin, Germany. “Availability of an omalizumab biosimilar in the EU is both timely and significant, offering a much-needed option for patients and healthcare providers. The clinical trial of Omlyclo™ clearly met the safety and efficacy endpoints, thereby offering a tangible promise for all eligible patients.”
“At this year’s EADV Congress, Celltrion reinforced dermatologists’ confidence in Omlyclo™, the first and only omalizumab biosimilar in Europe, by presenting robust clinical evidence supporting its biosimilarity and assuring physicians that switching from the original product to Omlyclo™ is safe,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “As a biosimilar-focused company, we remain committed to building long-term trust with healthcare professionals and strengthening our presence in the European market.”
To further its commitment to immunology, Celltrion presented an abstract for its proposed secukinumab biosimilar candidate, CT-P55 which demonstrated comparable efficacy and safety profiles to the reference secukinumab in healthy subjects.3
With the launch of Omlyclo™, Celltrion’s dermatology portfolio now comprises five products: Remsima™ (infliximab), Remsima™ SC (subcutaneous infliximab), Yuflyma™ (adalimumab), SteQeyma™ (ustekinumab), and Omlyclo™ (omalizumab), further strengthening the company’s presence in the treatment of immune-mediated skin conditions. Celltrion plans to continue solidifying its position in dermatology by advancing biosimilar candidates, including CT-P55, and expanding its post-commercialization activities within the therapeutic area.
