Celltrion Launches First Omalizumab Biosimilar Omlyclo in Europe, Starting with Norway
核心洞察
Celltrion has become the first pharmaceutical company to launch Omlyclo, an omalizumab biosimilar referencing Xolair, in the European market starting with Norway.
The biosimilar is approved for treating allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps across the EU.
Celltrion plans to expand Omlyclo to five additional European markets including Germany, Britain, Spain, France, and Italy to capture significant biosimilar market share.
South Korean biopharmaceutical company Celltrion Inc. has achieved a significant milestone by launching Omlyclo, the first omalizumab biosimilar in Europe, beginning with its commercial availability in Norway. The launch marks Celltrion's entry into the European anti-IgE (搜索) antibody market with a biosimilar referencing Novartis's Xolair.
First-Mover Advantage in European Market
Celltrion has secured first-mover advantage as the only company to bring an omalizumab biosimilar to the European market. The company plans to leverage this position to expand rapidly across key European territories, with Germany, Britain, Spain, France, and Italy identified as the next target markets.
"We are seeking to secure a major share in the biosimilar markets of those countries by launching the new product as quickly as possible," said Ha Tae-hoon, head of Celltrion's Europe division.
Therapeutic Applications and Clinical Evidence
Omlyclo has received European Commission approval for three key indications: allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP). At the EADV 2025 Congress, Celltrion presented robust clinical evidence supporting the biosimilarity of Omlyclo to the reference product, with data demonstrating that switching from the original omalizumab to Omlyclo is safe for patients.
The company has conducted comprehensive Phase 3 studies, including a double-blind, randomized, active-controlled trial comparing CT-P39 (Omlyclo) with reference omalizumab in chronic spontaneous urticaria patients, along with 16-week follow-up studies confirming efficacy and safety.
Expanding Dermatology Portfolio
The launch of Omlyclo strengthens Celltrion's dermatology portfolio, which now comprises five products: Remsima (infliximab), Remsima SC (subcutaneous infliximab), Yuflyma (adalimumab), SteQeyma (ustekinumab), and Omlyclo (omalizumab). This comprehensive portfolio positions the company as a significant player in treating immune-mediated skin conditions.
Celltrion is also advancing its pipeline with CT-P55, a proposed secukinumab biosimilar candidate currently undergoing global Phase III clinical trials. Early data presented at EADV 2025 showed CT-P55 demonstrated comparable efficacy and safety profiles to reference secukinumab in healthy subjects.
Strategic Growth Projections
Celltrion has significantly expanded its global biosimilar portfolio, with approved products increasing from six to 11. The company has set ambitious targets to commercialize 22 biosimilars by 2030, coinciding with projections that the global biosimilar market will grow from 138 trillion won this year to 261 trillion won by 2030.
"As a biosimilar-focused company, we remain committed to building long-term trust with healthcare professionals and strengthening our presence in the European market," said Taehun Ha, Senior Vice President and Head of Europe at Celltrion.
The successful launch of Omlyclo represents a strategic milestone for Celltrion as it continues to establish itself as a leading biosimilar developer with a focus on immunology and dermatology therapeutic areas.