On 21 March 2024, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorization for Omlyclo (omalizumab), Celltrion's biosimilar of the reference product Xolair.
This comes after news that the company has filed applications for the same product (also known as CT-P39) in Canada and the US.
Omalizumab is a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE) in the blood and interstitial fluid and to membrane-bound form of IgE (mIgE) on the surface of mIgE-expressing B lymphocytes. Unlike an ordinary anti-IgE antibody, it does not bind to IgE that is already bound by the high affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and antigen-presenting dendritic cells [1].
Omalizumab is used to treat asthma, as well as nasal polyps and chronic idiopathic urticaria (itchy rash). It is sold under the brand name Xolair by Novartis and was approved in the EU on 25 October 2005.
Omlyclo will be available as 75 mg and 150 mg solution for injection in pre-filled syringe and is intended for the treatment of severe persistent allergic asthma, severe chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU). With the CHMP recommendation, South Korea-based Celltrion expects final approval from the EC as early as May 2024. If so, this will be the first biosimilar of Xolair to be approved in Europe.
In early March 2024, Celltrion announced that the company had submitted a Biologics License Application (BLA) for CT-P39 to the US Food and Drug Administration (FDA). In late 2023, the company completed the submission of its marketing authorization application for CT-P39 to Health Canada.
The applications in all cases have included results from a global Phase III clinical trial designed to evaluate the efficacy, safety, and pharmacokinetics of CT-P39 compared to the reference product in 619 patients in six EU countries with chronic spontaneous urticaria (CSU) up to Week 40.
Other companies joining the omalizumab race include Alvotech/Advanz Pharma’s partnership for AVT23 in February 2023 [2] and US-based Kashiv Biosciences’ ADL018 [3]. Additionally, Moscow’s Generium launched its non-originator biological version of omalizumab (Xolair) on the Russian market in March 2022 [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of omalizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 7]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-omalizumab
2. GaBI Online - Generics and Biosimilars Initiative. Alvotech: rejection AVT02 in the US and new partnerships with Prolifarma and Advanz Pharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 7]. Available from: www.gabionline.net/biosimilars/news/alvotech-rejection-avt02-in-the-us-and-new-partnerships-with-prolifarma-and-advanz-pharma
3. GaBI Online - Generics and Biosimilars Initiative. Clinical trial advances for Kashiv and Celltrion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 7]. Available from: www.gabionline.net/biosimilars/research/clinical-trial-advances-for-kashiv-and-celltrion
4. GaBI Online - Generics and Biosimilars Initiative. Generium launches omalizumab (Xolair) non-originator in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 7]. Available from: www.gabionline.net/biosimilars/news/generium-launches-omalizumab-xolair-non-originator-in-russia
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