Celltrion Publishes Clinical Results of Humira Biosimilar in International Scientific Journal

Clinical Results from 204 Subjects in Japan
Confirmed Pharmacokinetic, Safety, and Immunogenicity Similarity to Original
Targeting 600 Billion Yen Japanese Adalimumab Market

[Asia Economy Reporter Myung-hwan Lee] Celltrion announced on the 10th that the Phase 1 clinical trial results of the autoimmune disease treatment Humira (generic name Adalimumab) biosimilar 'CT-P17' (brand name Yuflyma) were published in the SCI-level international journal 'Immunotherapy' on the 7th.

This paper was published based on the Phase 1 clinical trial results conducted in Japan, which confirmed the pharmacokinetic similarity between CT-P17 and the original drug, and evaluated safety and immunogenicity.

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

In the study, Celltrion divided a total of 204 healthy Japanese subjects into the CT-P17 administration group and the Adalimumab administration group, and after administration, observed them for 10 weeks, confirming pharmacokinetic (PK) similarity between the two groups. They also explained that safety and immunogenicity showed similarity between the comparative groups.

CT-P17, developed by Celltrion, is the world's first high-concentration Humira biosimilar to receive marketing authorization from the European Medicines Agency (EMA). Compared to the low concentration version, the drug dosage was reduced by half, and citrate, which can cause pain, was removed.

In October last year, Celltrion completed the approval application to the Japanese Ministry of Health, Labour and Welfare based on the Phase 1 clinical trial results of CT-P17 along with separately conducted global Phase 3 clinical trial results. Earlier in May, the Phase 1 clinical trial results were presented at the Japanese College of Rheumatology (JCR).

The original drug of CT-P17, Humira, is a blockbuster drug sold by AbbVie in the United States. According to IQVIA, a global pharmaceutical market research firm, Humira's global sales last year were approximately $31.6 billion (about 41 trillion 800 billion KRW). As of 2021, the Japanese Adalimumab market recorded about $487 million (about 633.1 billion KRW).

A Celltrion official stated, "The CT-P17 clinical results additionally published in the SCI-level international journal are expected to be used as a basis for medical professionals' prescriptions when the product obtains approval and is marketed locally in Japan." He added, "Celltrion plans to accelerate the approval process of CT-P17 through consultations with Japanese regulatory authorities and will do its best to ensure prompt supply as soon as approval is obtained."