Celltrion Announces European Commission Approval of Additional Line Extension for Omlyclo™ 300mg

Omlyclo™ (omalizumab) is the first and only omalizumab biosimilar approved in EuropeOmlyclo™ 300 mg/2ml prefilled syringe (PFS) presentation is now approved in EU offering a simpler dosing schedule and improved patient adherence

The European Commission (EC) has granted a line extension in the European Union (EU) for Celltrion’s Omlyclo™ (omalizumab), Europe’s first and only omalizumab biosimilar, for the 300 mg/2ml prefilled syringe (PFS).The European Commission (EC) approved Omlyclo™ 75 mg/0.5ml and 150mg/1ml solution for injection in pre-filled syringe in May 2024.

Omlyclo™ is indicated for the treatment of patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP).

“The additional strength of Omlyclo™ 300mg can significantly decrease the frequency of injections, and reduce injection burden and discomfort, without compromising efficacy and safety,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “These improvements may contribute to an enhanced treatment journey for patients by helping reduce the disease burden they face throughout their care. Given its distinctive product profile, Omlyclo™ 300mg has the potential to become an important additional option for the management of allergic diseases.”

Xolair^® (omalizumab) is designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, omalizumab minimizes the release of mediators throughout the allergic inflammatory cascade. Omalizumab has a patient exposure surpassing 1.99 million patient-years.¹ Its therapeutic effect has been established for more than 20 years through numerous clinical trials and real-world studies.

Notes to Editors:

About Omlyclo^™ (CT-P39, biosimilar omalizumab)

Omlyclo^™ is the first European Commission (EC) approved anti-IgE antibody biosimilar referencing Xolair^® (omalizumab). In the EU, Omlyclo^™ is indicated for the treatment of patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP).

About Celltrion, Inc.

Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook.

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Trademark

Xolair^® is a registered trademark of Novartis AG.

References

¹ Menzella F et al., Omalizumab for the treatment of patients with severe allergic asthma with immunoglobulin E levels above >1500 IU/mL. World Allergy Organ J. 2023 Jun 10;16(6):100787. doi: 10.1016/j.waojou.2023.100787. PMID: 37332525; PMCID: PMC10276275.

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