Celltrion receives European Commission approval of Omlyclo® (CT-P39), the first and only omalizumab biosimilar approved in Europe

• Omlyclo^® (CT-P39), used to treat allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU), becomes the first omalizumab biosimilar approved in the European Union
• The European Commission (EC) decision is based on clinical evidence, including results from a Phase III clinical trial demonstrating a comparable efficacy and safety profile with the reference product Xolair^®
• Omlyclo^® is the first omalizumab biosimilar in allergic diseases approved by the EC; the approval further bolsters the expansion of Celltrion’s biosimilar portfolio in Europe

May 23, 2024 INCHEON, South Korea - Celltrion today announced that the European Commission (EC) has approved Omlyclo^® (CT-P39), an omalizumab biosimilar referencing Xolair^®. Omlyclo^® is approved for the treatment of allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP).

The EC approval of Omlyclo^® follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March 2024.

The decision is based on clinical evidence, including results from a global Phase III clinical trial designed to evaluate the efficacy, safety and pharmacokinetics of Omlyclo^® compared to the reference product Xolair^® in patients with CSU up to Week 40.

“For more than two decades, omalizumab, a blockbuster monoclonal antibody anti-IgE, has revolutionised the management of chronic immune-mediated inflammatory diseases,” said Professor Marcus Maurer, Professor of Dermatology and Allergy, Co-Director for the Fraunhofer Site for Immunology and Allergology of the Fraunhofer Translational Medicine and Pharmacology ITMP and Executive Director for the Institute of Allergology, Charité - Universitätsmedizin Berlin, Germany. “The development of a biosimilar of omalizumab is a welcome solution to help alleviate some challenges with treatment access. The recently approved treatment Omlyclo^® has a comparable efficacy, safety and immunogenicity profile to Xolair^®.”

“Immunological conditions such as asthma can have a significant impact on the day-to-day lives of patients without appropriate treatment and care. This is why we are pleased to receive the first EC approval for an omalizumab biosimilar in Europe, an important step towards improving patient access to treatment. As we continue to expand our biosimilar offerings across the globe, building on our immunology and oncology product portfolio, we look forward to making a meaningful difference for patients living with immunological conditions,” said Hyoung-Ki Kim, Vice Chairman at Celltrion.

Omlyclo^® is Celltrion’s sixth biosimilar, besides Remsima^® SC, a subcutaneous formulation of infliximab, approved for use in the EU, following the approval of Remsima^® (biosimilar infliximab), Truxima^® (biosimilar rituximab), Herzuma^® (biosimilar trastuzumab), Yuflyma^® (biosimilar adalimumab), and Vegzelma^® (biosimilar bevacizumab). Omlyclo^® is currently under review by the U.S. Food and Drug Administration (FDA), following the submission in March 2024.