Celltrion Biosimilars Demonstrate Positive Results in Clinical Trials, Paving Way for Expanded Access to Key Treatments
SUWON, South Korea – New data presented throughout 2025 reinforces celltrion Inc.’s position as a leading biosimilar developer, with promising results from trials evaluating CT-P39, a biosimilar to Xolair® (omalizumab), and CT-P55, a biosimilar to Secukinumab. The findings, detailed in recent publications and conference presentations, suggest comparable efficacy, safety, and immunogenicity profiles to their reference products, perhaps offering more affordable treatment options for patients with chronic conditions.
These developments are significant as biosimilars are increasingly recognized for their potential to lower healthcare costs and broaden patient access to vital medications. Celltrion’s advancements in this space directly impact individuals suffering from chronic spontaneous urticaria and psoriasis, conditions affecting millions globally. Prosperous biosimilar adoption relies on demonstrating equivalence to originator biologics, and the data released by Celltrion aims to build confidence among physicians and patients alike, potentially accelerating market penetration and driving down overall treatment expenses.
A Phase 3 study, led by Sarbjit Singh Saini and colleagues, showed CT-P39 demonstrated comparable efficacy to reference omalizumab in treating chronic spontaneous urticaria.1 Further supporting this,a study by Grattan C et al. revealed CT-P39’s efficacy and safety over a 16-week period in the same condition.2 Regarding CT-P55, a comparison with reference secukinumab in healthy male subjects indicated similar pharmacokinetic, safety, and immunogenicity profiles.3 Research by Karle et al. previously indicated that secukinumab itself exhibits low immunogenicity potential, a characteristic mirrored in the CT-P55 biosimilar.4
Celltrion Inc. notes that all forward-looking statements are based on current beliefs and expectations and are subject to inherent risks and uncertainties. The company does not assume any obligation to update these statements unless required by applicable securities laws. Xolair® remains a registered trademark of Novartis AG.
