Celltrion Expands Omlyclo ® Portfolio in Europe with Launch of 300 mg Strength

Celltrion (KRX: 068270) today announced the launch of the 300 mg strength of Omlyclo^® (omalizumab), a treatment for chronic spontaneous urticaria and allergic asthma, in Europe.¹ With the addition of the 300 mg strength, Celltrion has expanded its Omlyclo^® portfolio to include multiple dose strengths and device presentations for patients, healthcare professionals and healthcare institutions.

Following the European launch of Omlyclo^® 75 mg and 150 mg late last year, Celltrion began rolling out the 300 mg strength in key markets including Germany, the UK and France in the middle of this year. Celltrion is gradually expanding supply to other European countries and plans to complete the rollout across Europe by the end of the year.

Celltrion is offering Omlyclo^® 300 mg in both pre-filled syringe (PFS) and autoinjector (AI) presentations, allowing patients and healthcare professionals a choice of device depending on the treatment setting and individual patient needs. This comprehensive portfolio provides greater flexibility in dose strengths and device options.

Celltrion will continue to provide product information to healthcare professionals and institutions as part of its commercial activities across Europe.

“The launch of Omlyclo^® 300 mg allows us to offer patients and healthcare professionals more convenient and flexible treatment options,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion. “Building on the first omalizumab biosimilar¹ advantage and broad product portfolio, we will continue to strengthen our competitive position in key tenders and work to sustain Omlyclo^®’s strong growth momentum across Europe throughout the second half.”

About OMLYCLO^® (CT-P39, biosimilar omalizumab¹)

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, haematology, 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.

Reference

¹ European Medicines Agency. Summary of Product Characteristics (SmPC), Omlyclo. [Last Accessed August 2026]

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