Celltrion Submits Clinical Trial Plan for Phase 3 Study on Interchangeability of Uplyma and Humira to European Regulators

Celltrion Biosimilar 'Yuflyma'

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 23rd that it has submitted a global Phase 3 clinical trial plan to European regulatory authorities to secure interchangeability between the autoimmune disease treatment 'CT-P17 (Yuflyma, generic name Adalimumab)' and the original drug Humira.

This global Phase 3 trial will be conducted in multiple European countries including Estonia and Poland, targeting 366 patients with plaque psoriasis. It will compare and verify pharmacokinetics, efficacy, and safety between multiple crossover dosing groups of Yuflyma and Humira and a Humira maintenance dosing group.

Previously, Celltrion confirmed similar efficacy, pharmacokinetics, and safety results between Yuflyma and Humira through a global Phase 3 clinical trial on rheumatoid arthritis patients. Based on these clinical results, Celltrion obtained European marketing authorization for Yuflyma from the European Medicines Agency (EMA) in February last year for all indications held by Humira, including rheumatoid arthritis, inflammatory bowel disease, and psoriasis, and is currently supplying the product.

Additionally, Celltrion has completed a patent agreement with the developer AbbVie in the United States to begin sales from July next year, and expects to receive sales approval from the U.S. Food and Drug Administration (FDA) within this year.

Yuflyma, developed by Celltrion, is the first high-concentration Humira biosimilar approved by the EMA. It features a reduction of the drug dosage by half compared to the low concentration version and the removal of citrate, which can cause pain.

A Celltrion official stated, “If Yuflyma secures interchangeable biosimilar status through the interchangeability clinical trial, it will greatly help strengthen competitiveness and expand market share. We will do our best to thoroughly prepare for clinical trials and approvals, and to supply high-quality biosimilars at reasonable prices to global markets including Korea.”

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