The European Commission (EC) has approved Celltrion’s Omlyclo (CT-P39) – the first and only omalizumab biosimilar for reference product Xolair to be authorised in Europe to treat allergic conditions.
The approval is granted to treat chronic spontaneous urticaria (CSU), allergic asthma and chronic rhinosinusitis with nasal polyps.
This regulatory milestone follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommendation for marketing authorisation in March 2024.
The EC’s decision to approve Omlyclo is underpinned by robust clinical evidence, including findings from a global Phase III study.
The study assessed the safety, efficacy and pharmacokinetics of Omlyclo in comparison to the reference product Xolair in CSU patients up to week 40.
Omlyclo represents the sixth biosimilar from Celltrion’s portfolio to receive approval for use in the EU, joining the ranks of other approved biosimilars such as Herzuma (trastuzumab), Remsima (infliximab), Remsima SC (subcutaneous infliximab), Truxima (rituximab), Vegzelma (bevacizumab)and Yuflyma (adalimumab).
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In addition to its recent EC approval, Omlyclo is currently under review by the US Food and Drug Administration, following a submission in March 2024.
Celltrion vice-chairman Hyoung-Ki Kim stated: “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.”
