EMA recommends approval of first omalizumab biosimilar Omlyclo

Biosimilars/News | Posted 07/05/2024 post-comment0 Post your comment

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].

Related article
Biosimilar pipelines for South Korean firms: Celltrion and Samsung Bioepis

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Se lanza la Estrategia de Certidumbre Regulatoria para biosimilares en México

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Se lanza la Estrategia de Certidumbre Regulatoria para biosimilares en México

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 


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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010