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Review
. 2025 Nov 12.
doi: 10.1007/s40261-025-01505-z. Online ahead of print.

CT-P39: An Omalizumab Biosimilar

Michael B Brown  1
Affiliations
Review

CT-P39: An Omalizumab Biosimilar

Michael B Brown. Clin Drug Investig. .

Abstract

CT-P39 [Omlyclo® (omalizumab-igec)] is a biosimilar of the reference monoclonal anti-immunoglobulin E (IgE) antibody omalizumab. It is approved for use in all indications for which reference omalizumab is approved, including allergic asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria (CSU) and (in the USA) IgE-mediated food allergy. CT-P39 has similar physicochemical and pharmacodynamic properties to those of reference omalizumab, and the pharmacokinetic equivalence and comparability of the agents has been demonstrated in healthy volunteers and patients with CSU, respectively. CT-P39 demonstrated clinical efficacy equivalent to that of reference omalizumab in patients with CSU and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of CT-P39 were similar to those of reference omalizumab, and switching from reference omalizumab to CT-P39 appeared to have no impact on efficacy or safety. The role of reference omalizumab in the management of allergic asthma, chronic rhinosinusitis with nasal polyps, CSU and IgE-mediated food allergy is well established and CT-P39 provides an effective alternative for patients requiring omalizumab therapy.

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Conflict of interest statement

Declarations. Authorship and Conflict of Interest: During the peer review process, the manufacturer of the agent under review, Celltrion Inc., was offered an opportunity to comment on this article. Changes resulting from the comments received from Aram Kang, PharmD and Dong-Hyeon Kim, DVM, PhD, were made on the basis of scientific completeness and accuracy. Michael B. Brown is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content. Ethics Approval, Consent to Participate, Consent to Publish, Availability of Data and Material, Code Availability: Not applicable.

References

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    1. Celltrion Inc. OMLYCLO® (omalizumab-igec) injection, for subcutaneous use: US prescribing information. 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761399s000lbl.pdf . Accessed 29 Oct 2025.
    1. European Medicines Agency. Omlyclo (international non-proprietary name: omalizumab): EU assessment report. 2024. https://www.ema.europa.eu/en/documents/assessment-report/omlyclo-epar-pu... . Accessed 29 Oct 2025.
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