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.

Notes to Editors:

About Omlyclo™ (omalizumab)

Omlyclo™is the first European Commission (EC) approved anti-IgE antibody biosimilar referencing Xolair^® (omalizumab). In the EU, Omlyclo™ is indicated for the treatment of patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP).

About CT-P55 (biosimilar candidate of secukinumab)

CT-P55 is a proposed biosimilar of reference secukinumab developed by Celltrion, Inc. Secukinumab is a human monoclonal antibody that selectively targets interleukin-17A and has been demonstrated to be highly efficacious in the treatment of moderate to severe plaque psoriasis, starting at early time points, with a sustained effect and a favorable safety profile.⁴ CT-P55 is currently undergoing global Phase III clinical trials.

About Celltrion

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook.

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Trademark

Xolair^® is a registered trademark of Novartis AG.

References

¹ Sarbjit Singh Saini et al., CT-P39 Compared With Reference Omalizumab in Chronic Spontaneous Urticaria: Results From a Double-Blind, Randomized, Active-Controlled, Phase 3 Study. Available at: https://onlinelibrary.wiley.com/doi/pdf/10.1111/all.16446?msockid=30d535870b30638b14c920090a18627c [Last accessed August 2025]

² Grattan C et al., Efficacy and safety of CT-P39, an omalizumab biosimilar, in chronic spontaneous urticaria: 16-week follow-up study. Clin Transl Allergy. 2025 Jun;15(6):e70069.

³ Hasunuma et al., Pharmacokinetics, Safety and Immunogenicity comparision of Secukinumab Biosimilar (CT-P55) with Reference Secukinumab in Healthy male Subjects. E-poster presentation (abstract no. 122) Presented at EADV 2025.

⁴ Karle et al., Secukinumab, a novel anti-IL-17A antibody, shows low immunogenicity potential in human in vitro assays comparable to other marketed biotherapeutics with low clinical immunogenicity. mAbs. 2016;8(3):536-50. doi:10.1080/19420862.2015.1136761

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