Celltrion "Zoleair Biosimilar Confirms Efficacy in Phase 3 Clinical Trial"

Celltrion announced on the 10th that it has disclosed the global Phase 3 clinical trial results of the biosimilar 'CT-P39' of the allergic asthma and chronic urticaria treatment 'Xolair (active ingredient omalizumab)' and confirmed its efficacy and equivalence compared to the original drug.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

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Celltrion is conducting a clinical trial over 40 weeks after the first dose on 619 patients with chronic spontaneous urticaria in six countries including Poland and Bulgaria. The current results are from the clinical data up to 24 weeks.

Celltrion measured the change in weekly itch score at 12 weeks from baseline as the primary endpoint in the CT-P39 300 mg treatment group and the original drug 300 mg treatment group. The results showed that CT-P39 met the predefined equivalence criteria. Similar results to the original drug were also confirmed in secondary endpoints including efficacy, pharmacokinetics, safety, and immunogenicity assessments.

Celltrion plans to complete the remaining Phase 3 clinical trials of CT-P39 and sequentially apply for approval in major domestic and overseas countries within this year.

Xolair is an antibody biopharmaceutical developed by Genentech and Novartis, used for the treatment of allergic asthma, chronic urticaria, and chronic rhinosinusitis. It recorded global sales of approximately 5 trillion KRW as of 2022, making it a blockbuster product. The substance patent has already expired, and the formulation patents are set to expire in March 2024 in Europe and November 2025 in the United States, respectively.

A Celltrion official stated, "Since CT-P39 has proven efficacy and equivalence compared to the original drug in the global Phase 3 clinical trial and confirmed similarity in safety, we plan to complete the remaining clinical procedures smoothly and accelerate the approval process. Celltrion will continue to expand its product portfolio with various indications such as allergic diseases and ophthalmic diseases following its strengths in autoimmune diseases and anticancer drugs."

Meanwhile, on the 3rd, Celltrion disclosed the global Phase 3 clinical trial results confirming efficacy equivalence and safety of the biosimilar 'CT-P42' of the ophthalmic disease treatment 'Eylea (active ingredient aflibercept)' compared to the original drug. In addition, Celltrion is also developing follow-up biosimilars such as CT-P41 (Prolia biosimilar), CT-P43 (Stelara biosimilar), and CT-P47 (Actemra biosimilar).

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