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EC approves Celltrion’s Omlyclo for allergic conditions
24 May 2024
Drug ApprovalPhase 3ImmunotherapyClinical Result
Omlyclo is approved for the treatment of chronic spontaneous urticaria, allergic asthma and chronic rhinosinusitis with nasal polyps. Credit: voronaman / Shutterstock.com.
Omlycloopean Commission (EC) has approvedchronic spontaneous urticaria –allergic asthmaonly chronic rhinosinusitisfor renasal polypsuct Xolair to be authorised in Europe to treat allergic conditions.
The approval is granted to treat chronic spontaneous urticaria (CSU), allergic asthma and chomalizumabosinusitis with nasal polyps.Xolair
This regulatory milestone followschronic spontaneous urticaria (CSU)mmallergic asthmainal chronic rhinosinusitis (CHMPnasal polypstion for marketing authorisation in March 2024.
The EC’s decision to approve Omlyclo iEuropean Medicines Agencylinical evidence, including findings from a global Phase III study.
The study assessed the safetyOmlycloacy 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).
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.
Omlyclocontinue to expand our biosimilar offerings across the globe, building on our immunology and oncology product portfolio, we look forward to making a meaninHerzumafftrastuzumabpatRemsimaivinfliximabmmuRemsimaal conditions.”infliximabTruximarituximabVegzelmaYuflymaadalimumab
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