Celltrion Launches 300-mg Strength Omlyclo in Europe

Editor’s Take: With this expansion, Omlyclo’s portfolio now includes not only multiple dose strengths, but also multiple device presentations.

Celltrion launched a 300-mg strength version of Omlyclo (omalizumab) in Europe, joining 75- and 150-mg doses made available in 2025. The drug is a treatment for chronic spontaneous urticaria and allergic asthma.

Omlyclo is the first anti-immunoglobulin E (IgE) antibody biosimilar referencing Genentech and Novartis’ Xolair approved by the European Commission (EC). A third indication for the drug is chronic rhinosinusitis with nasal polyps.

In the United States, the FDA approved Omlyclo in March 2025.

Why 300-mg Dose Matters

The launch signifies Omlyclo’s availability not only in multiple dose strengths, but also multiple device presentations. Omlyclo 300 mg is being offered in either a prefilled syringe (PFS) or autoinjector (AI) option. This, Celltrion says, affords both patients and healthcare professionals choices dependent on treatment settings and individual needs.

Celltrion had rolled out the 300-mg dose in markets including Germany, the United Kingdom, and France throughout 2026 to date. The company plans to gradually expand to all of Europe by the end of the year.

Omlyclo Key to Celltrion Success

Taehun Ha, Celltrion Senior Vice President and Head of Europe, applauded the 300-mg launch. Ha said it builds upon the “first omalizumab biosimilar advantage.”

“[This] allows us to offer patients and healthcare professionals more convenient and flexible treatment options,” Ha said. “We will continue to strengthen our competitive position in key tenders and work to sustain Omlyclo’s strong growth momentum.”

Celltrion plans to continue providing product information on Omlyclo to healthcare professionals and institutions in the biosimilar’s commercial rollout.