EURETINA reveals phase 3 52-week results of ‘Ideenzheldt’ (CT-P42),
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, “Celltrion announced the global phase 3 52-week results of the biosimilar ‘Ideenzheldt’ (CT-P42) for the treatment of ocular diseases at the European Retina Society (EURETINA) on the 23rd.”,
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, ‘EURETINA is an international society established to promote the sharing of knowledge on vitreoretinal and macular diseases among European retina specialists and is considered one of the major European congresses in the field of ophthalmology. This year, it took place in Barcelona, Spain from the 19th to the 22nd of this month.’,
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, ‘Celltrion presented the results of the global phase 3 study conducted with 348 diabetic macular edema (DME) patients during the first day’s presentation session of the congress. The trial randomly assigned DME patients to the CT-P42 treatment group and the original drug treatment group to evaluate the efficacy and safety of CT-P42 over 52 weeks compared to the original drug.’,
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, ‘According to the clinical results, both treatment groups showed a steady increase in best-corrected visual acuity (BCVA) from baseline up to week 16, which was then stably maintained until week 52, demonstrating the long-term therapeutic efficacy of CT-P42. Additionally, similar outcomes were observed in other secondary efficacy evaluation variables such as average change in central retinal thickness, as well as in terms of safety.’,
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, ‘Celltrion plans to establish a tailored sales strategy and prepare for the market launch to ensure rapid market penetration upon obtaining approval in key countries, given that the efficacy and safety of CT-P42 have been confirmed in the global phase 3 clinical trials.’,
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, ‘The original product of Ideenzheldt, Aylea, is a blockbuster ophthalmic therapeutic agent that achieved global sales of $9.36 billion (~12.168 trillion KRW) last year. Celltrion has completed the submission of CT-P42 marketing authorizations in major countries such as the United States, Canada, and Europe last year, and the approval process is currently ongoing. In Korea, the product was approved in May this year, and its price was finalized before entering the market.’,
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, ‘A Celltrion official stated, “Through the announcement of the results at the European Retina Society, CT-P42 has once again confirmed its efficacy and safety compared to the original drug,” and added, “We will do our best to expand our product portfolio in the ophthalmic disease market and strengthen our leading position by smoothly proceeding with the remaining approval process.”‘,
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, “Recently, Celltrion has been strengthening its dominance in the global market and expanding its sales expectations by consecutively obtaining marketing authorizations for follow-up products such as Omliclo (Jolutent biosimilar) and Stegima (Stelara biosimilar).”