EC Approves Celltrion's Omlyclo for Allergies

The European Commission (EC) has officially approved Celltrion's Omlyclo (CT-P39), marking it as the first omalizumab biosimilar authorized in Europe for the treatment of various allergic conditions. This groundbreaking approval allows Omlyclo to be used for chronic spontaneous urticaria (CSU), allergic asthma, and chronic rhinosinusitis with nasal polyps. The decision follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation for marketing authorization, which was issued in March 2024.

The EC's approval of Omlyclo is grounded in robust clinical evidence, notably from a global Phase III study. This study evaluated the safety, efficacy, and pharmacokinetics of Omlyclo in comparison to the reference product Xolair, focusing on CSU patients over a period extending to week 40. This comprehensive assessment played a pivotal role in substantiating the clinical viability of Omlyclo, leading to its regulatory approval.

Omlyclo is the sixth biosimilar in Celltrion’s portfolio to gain approval for use in the European Union, joining a distinguished lineup of biosimilars including Herzuma (trastuzumab), Remsima (infliximab), Remsima SC (subcutaneous infliximab), Truxima (rituximab), Vegzelma (bevacizumab), and Yuflyma (adalimumab). This recent addition underscores Celltrion’s expanding influence in the global biosimilar market, particularly in the fields of immunology and oncology.

Beyond its recent European approval, Omlyclo is also under review by the US Food and Drug Administration (FDA), following a submission made in March 2024. This ongoing review highlights the potential for Omlyclo to gain broader acceptance and availability in major pharmaceutical markets around the world.

Hyoung-Ki Kim, Vice-Chairman of Celltrion, emphasized the significance of this approval, particularly for patients suffering from immunological conditions such as asthma. He noted that without appropriate treatment and care, such conditions can severely affect the daily lives of patients. Kim expressed satisfaction with the EC's approval, seeing it as a crucial step forward in enhancing patient access to essential treatments.

Kim further stated that the approval of Omlyclo aligns with Celltrion's broader strategy of expanding its biosimilar offerings globally. This strategy is aimed at making meaningful improvements in the lives of patients with immunological conditions by building on the company's existing immunology and oncology product portfolio. As Celltrion continues to forge ahead in the biosimilar market, the company remains committed to advancing healthcare outcomes for patients worldwide.

In summary, the EC's approval of Omlyclo represents a significant milestone in the treatment of allergic conditions in Europe. Supported by extensive clinical data, this decision not only reinforces the credibility of Omlyclo but also enhances Celltrion’s position in the competitive biosimilar market. With ongoing reviews and potential approvals in other major markets, Omlyclo is poised to become an essential treatment option for patients suffering from chronic spontaneous urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps.