Celltrion Presents Phase 1 Clinical Trial Results of 'Yuflyma' at Japanese Rheumatology Conference

Humira Biosimilar Clinical Trial in Japanese Subjects
Pharmacokinetics and Safety Similar to Original Confirmed
Goal to Apply for Japanese Approval Within the Year

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 23rd that it presented the Phase 1 clinical trial results of the biosimilar to the autoimmune disease treatment Humira (generic name Adalimumab), 'Yuflyma (CT-P17),' at the Japan College of Rheumatology (JCR).

JCR is one of the global rheumatology societies that publishes and discusses research results on the onset, treatment, and prevention of rheumatism. Celltrion conducted the Phase 1 clinical trial of Yuflyma on healthy Japanese subjects, and the clinical results have been disclosed online since the 20th of this month.

After dividing a total of 204 subjects into the Yuflyma administration group and the Adalimumab administration group and observing the progress for 10 weeks after a single dose, Celltrion confirmed pharmacokinetic (PK) similarity between the two groups. Additionally, no adverse events caused by the drug administration occurred, showing comparable safety between the groups.

Yuflyma is the world's first high-concentration Humira biosimilar to receive marketing authorization from the European Medicines Agency (EMA). It has differentiated competitiveness by reducing the drug dose by half compared to the low concentration and removing citrate, which can cause pain.

Celltrion obtained marketing authorization last year from global regulatory agencies such as the EMA, the Ministry of Food and Drug Safety, and Health Canada for all indications that Humira holds, including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis (PS). In February this year, it received additional marketing authorization in Europe for the 80mg/0.8ml dosage form following the 40mg/0.4ml dosage.

The original drug of Yuflyma, Humira, is a blockbuster biopharmaceutical sold by AbbVie in the United States, recording sales of approximately $20.7 billion (about 25.5645 trillion KRW) last year. According to IQVIA data last year, the Japanese Adalimumab market was about $487 million (about 601.6 billion KRW), and Celltrion aims to apply for Yuflyma's approval in Japan within this year.

A Celltrion official said, "Yuflyma has completed market entry in Korea as well as Europe and North America, and pharmacokinetics and safety have been confirmed in clinical trials on Japanese subjects. Based on these clinical results, we will proceed smoothly with the remaining approval procedures and do our best to enter the Japanese Adalimumab market as soon as possible."

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