Canada approves first omalizumab biosimilar Omlyclo

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Canada approves first omalizumab biosimilar Omlyclo

Biosimilars/News | Posted 06/02/2025 0 Post your comment

On 6 December 2024, Health Canada approved Celltrion’s Omlyclo (CT-P39) omalizumab biosimilar – the first and only omalizumab biosimilar currently available in Canada. The product is a biosimilar of Novartis’ Xolair.

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 Canada since 2004.

Omlyclo is approved for the indications of allergic asthma (adult and paediatric patients – 6 years of age and above), chronic rhinosinusitis with nasal polyposis (CRSwNP), and chronic idiopathic urticaria (CIU).

Omlyclo joins Celltrion’s other biosimilar products, such as Herzuma (trastuzumab); Remsima/Remsima SC (infliximab); Steqeyma (Ustekinumab); Truxima (rituximab); Vegzelma (bevacizumab); Yuflyma (adalimumab), that have all been approved in Canada [2].

Omlyclo has already been approved and is available in Europe in May 2024 [3].

Three more biosimilar approvals in Canada in 2023

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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 2025 Feb 6]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-omalizumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canad a
3. GaBI Online - Generics and Biosimilars Initiative. EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 6]. Available from: www.gabionline.net/biosimilars/news/ec-biosimilar-approvals-omlyclo-jubbonti-wyost-and-pyzchiva
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of first omalizumab biosimilar Omlyclo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 6]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-first-omalizumab-biosimilar-omlyclo

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