The European Commission (EC) has approved a line extension for Celltrion’s Omlyclo (omalizumab), Europe’s first omalizumab biosimilar, authorizing a 300 mg/2 ml pre-filled syringe for use in the European Union.

The product previously received approval in May 2024 for the 75 mg per 0.5 ml and 150 mg per 1 ml pre-filled syringe formats.

Omlyclo is an antibody biopharmaceutical with the same composition as the original drug, Novartis' Xolair, which has indications that include allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps. Xolair recorded approximately 6 trillion won ($4.1 billion) in global sales in 2024.

Omalizumab works by targeting and blocking immunoglobulin E. By reducing free IgE, down-regulating high-affinity IgE receptors, and limiting mast cell degranulation, the therapy helps prevent the release of mediators that drive the allergic inflammatory cascade. Omalizumab has accumulated more than 1.99 million patient-years of exposure, with its therapeutic effect supported by over twenty years of clinical trials and real-world evidence.

“The additional strength of Omlyclo 300 mg can significantly decrease the frequency of injections and reduce injection burden and discomfort without compromising efficacy and safety,” Celltrion Vice President of Global Medical Affairs Lee Nam said. “These improvements may help ease the disease burden patients face throughout their treatment. Given its unique profile, Omlyclo 300 mg has the potential to become an important option in the management of allergic diseases.”