Celltrion Submits Clinical Trial Plan for 'CT-P17' Humira Interchangeability Phase 3 to US FDA

Celltrion Humira Biosimilar 'Yuflyma'

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 1st that it has submitted a global Phase 3 clinical trial plan (IND) to the U.S. Food and Drug Administration (FDA) to secure interchangeability between the autoimmune disease treatment 'CT-P17 (generic name Adalimumab, product name Yuflyma)' and the original drug Humira.

Celltrion plans to conduct a global Phase 3 clinical trial involving 366 patients with plaque psoriasis. The study will compare and verify pharmacokinetics, efficacy, and safety between groups receiving multiple crossover doses of Yuflyma and Humira and the group maintained on Humira.

Yuflyma, developed by Celltrion, is a high-concentration Humira biosimilar that was the first in the world to receive approval from the European Medicines Agency (EMA). It was developed with a formulation that halves the drug dosage compared to the low concentration version and removes citrate, which can cause pain.

Yuflyma has already obtained approval for all indications held by Humira, including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PS), and has started sales in major European countries. In March of this year, it also began full-scale sales procedures in South Korea. In the U.S., Celltrion has completed a patent agreement with AbbVie, the developer, to enable sales starting July 1 next year.

In addition to the advantages of Yuflyma's high-concentration formulation, Celltrion plans to expand its market share globally, including in the U.S., by securing the interchangeable biosimilar status for Humira through interchangeability clinical trials.

Humira recorded sales of approximately $20.694 billion (about 27 trillion KRW) last year, ranking second in global pharmaceutical sales. In the largest market, the U.S., sales reached $17.33 billion (about 22 trillion KRW). Particularly, since AbbVie, the original drug developer, launched the high-concentration formulation of Humira, the market has rapidly reorganized, especially in the U.S. According to IQVIA, a global pharmaceutical market research firm, over 80% of Humira sold in the U.S. last year was the high-concentration formulation.

A Celltrion official stated, “If Yuflyma, planned for launch in the U.S., the world's largest pharmaceutical market, secures interchangeable biosimilar status, pharmacists will be able to substitute the original drug with Yuflyma upon prescription, which will be a crucial factor determining the competitiveness of Humira biosimilars in the future. We will also do our best to prepare for the launch in the U.S. market to provide high-quality biopharmaceuticals at reasonable prices to U.S. medical professionals and patients.”

This content was produced with the assistance of AI translation services.