Celltrion Gains Approval to Amend Phase 3 IND for CT-P55, Boosting Cost and Timeline Savings

Celltrion has received approval in Europe to significantly reduce the number of patients in the global Phase 3 clinical trial of CT-P55, its biosimilar to Cosentyx (ingredient name: secukinumab). This measure is expected to substantially shorten both development costs and timelines.

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Celltrion announced on the 11th that on the 9th (local time) it obtained approval from the European Medicines Agency (EMA) for an amendment to its investigational new drug (IND) application to reduce the number of enrolled patients in the CT-P55 global Phase 3 trial from the original 375 to 153. Celltrion expects that, by cutting the target for patient recruitment and the number of enrolled patients, it will be able to reduce development costs while also shortening the overall clinical trial period.

This approval reflects the EMA's policy to improve the efficiency of biosimilar development. Recently, the EMA and the U.S. Food and Drug Administration (FDA) have been accelerating discussions on exempting or simplifying Phase 3 trials aimed at demonstrating efficacy equivalence. Clinical trial simplification is expected to become possible only in cases where sufficient scientific evidence is anticipated. By reducing clinical trial costs and duration, the overall development cost is likewise expected to decrease significantly.

Celltrion is currently conducting a global Phase 3 clinical trial in patients with plaque psoriasis to demonstrate the efficacy, safety, and equivalence of CT-P55 compared with the originator drug Cosentyx. Cosentyx is an interleukin (IL)-17A inhibitor used as a treatment for autoimmune diseases such as ankylosing spondylitis, psoriatic arthritis, and moderate-to-severe plaque psoriasis. As of 2025, its global sales are expected to be approximately 6.668 billion dollars (about 9.3352 trillion won), and its substance patents are scheduled to expire in January 2029 in the United States and July 2030 in Europe.

Celltrion plans to build an even stronger product portfolio in the autoimmune disease treatment field by accelerating the development of CT-P55. The company has already launched a wide range of autoimmune disease therapies in major countries around the world, from tumor necrosis factor-alpha (TNF-α) inhibitors to interleukin inhibitors, including Remsima, Yuflyma, Zymfentra (Remsima SC), Steqima, and Abtozma.

A Celltrion official said, "This approval is an achievement based on our unrivaled biosimilar development capabilities and the trust of regulatory authorities," adding, "We will invest the saved costs into building our follow-up pipeline to secure sustainable growth drivers."

Meanwhile, in addition to CT-P55, Celltrion is developing multiple follow-up pipelines such as CT-P51 (Keytruda biosimilar), CT-P44 (Darzalex biosimilar), and CT-P52 (Taltz biosimilar. In the new drug segment, the company has unveiled a development roadmap for a 16-product pipeline that includes antibody-drug conjugates (ADCs), multispecific antibodies, fetal Fc receptor (FcRn) inhibitors, and obesity treatments. Four product candidates, including ADC candidates CT-P70, CT-P71, and CT-P73 and multispecific antibody candidate CT-P72, entered human clinical stages last year.

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