CT-P39: An Omalizumab Biosimilar

<p dir="ltr"><b>Funding</b> The preparation of this review was not supported by any external funding.</p><p dir="ltr"><b>Declarations </b></p><p dir="ltr"><b>Authorship and Conflict of interest</b> 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.</p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</b> Not applicable.</p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank"><b>here</b></a>.</p><p dir="ltr">Abstract <br>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.</p><p dir="ltr"><br></p><p dir="ltr">© The Author(s), under exclusive licence to Springer Nature Switzerland AG 2025</p>