Wednesday, May 29, 2024
Celltrion today announced that the European Commission (EC) has approved Omlyclo ® (CT-P39), an omalizumab biosimilar drug referring to Xolair ® . Omlyclo ® is approved for the treatment of allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP).
The CE approval of Omlyclo ® follows the marketing authorization recommendation 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 of CSU until week 40.
“For more than twenty years, omalizumab, a successful anti-IgE monoclonal antibody, has revolutionized the management of chronic immune-mediated inflammatory diseases,” says Marcus Maurer, professor of dermatology and allergology, co-director of the Fraunhofer site for immunology and allergology of the Fraunhofer Translational Medicine and Pharmacology ITMP and executive director of the Institute of Allergology at Charité - Universitätsmedizin Berlin, Germany. “The development of a biosimilar to omalizumab is a welcome solution to help resolve some treatment access issues. The recently approved Omlyclo ® treatment has an efficacy, safety and immunogenicity profile comparable to that of Xolair ® . »
“Immunological diseases such as asthma can have a significant impact on patients' daily lives if they do not receive appropriate treatment and care. This is why we are pleased to receive the first CE approval for an omalizumab biosimilar in Europe, an important step in improving patient access to treatment. As we continue to expand our biosimilar drug offerings across the world building on our portfolio of immunology and oncology products, we look forward to making a meaningful difference for patients living with immunological diseases,” said Hyoung-Ki Kim, vice president of Celltrion.
Omlyclo ® is Celltrion's sixth biosimilar drug, in addition to Remsima ® SC, a subcutaneous formulation of infliximab, which has been approved for use in the EU, following the approval of Remsima ® (infliximab biosimilar), Truxima ® (rituximab biosimilar), Herzuma ® (trastuzumab biosimilar), Yuflyma ® (adalimumab biosimilar) and Vegzelma ® (bevacizumab biosimilar). Omlyclo ® is under review by the US Food and Drug Administration (FDA), following submission in March 2024.
About OMLYCLO ® (CT-P39, omalizumab biosimilar)
Omlyclo ® is the first anti-IgE antibody biosimilar medicine approved by the European Commission (EC) 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
Celltrion is a leading biopharmaceutical company based in Incheon, South Korea, focused on the research, development, manufacturing, marketing and sales of innovative therapeutic products that improve the lives of people around the world. The Company's solutions include world-class monoclonal antibody biosimilar medicines such as Remsima ® , Truxima ® and Herzuma ® , providing broader access to patients globally. Celltrion has also received FDA and CE approval in the United States for Vegzelma ® and Yuflyma ® , FDA approval for Zymfentra™ and CE approval for Remsima ® SC. To learn more, visit www.celltrion.com/en-us .
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Source: businesswire.com
