Celltrion Applies to Europe for IND to designate Yuflyma

Humira-Yuflyma interchangeable efficacy clinical trial in Europe after the United States

Celltrion announced on the 23rd that it has applied to European regulators for IND to designate Humira biosimilar Yuflyma (CT-17) as an interchangeable similar.

 

If it is designated as an interchangeable similar, it can be prescribed by replacing the original at a pharmacy without intervention by MD.

 

Celltrion recently submitted IND to the U.S.

 

Food and Drug Administration (FDA) to secure a mutual exchange between Yuflyma and Humira.

 

European clinical trials are conducted on 366 Plaque psoriasis patients in many countries, including Estonia and Poland.

 

It plans to compare and verify pharmacokinetics, efficacy, and safety between the multiple cross-medication group between Yuflyma and Humira and the Humira maintenance medication group.

 

Celltrion previously confirmed the efficacy, pharmacokinetics, and safety results similar to Humira through Global Phase 3 clinical trials of Yuflyma in patients with rheumatoid arthritis.

 

Based on the clinical results, Yuflyma obtained permission to sell all indications held by Humira, such as RA, IBD, and PS, from EMA in February 2021 and is in progress.

 

In the U.S., it has completed a patent agreement in the U.S.

 

with its developer AbbVie so that it can start selling on July 1st next year.

 

Celltrion expects FDA approval to sell Yuflyma within this year.

 

When sales of Yuflyma begin in the U.S., it is expected that the advantages of high-concentration formulation, whether to secure interchangeable similarity status, and clinical results on various indications will serve as important competitiveness.

 

Yuflyma is the first high-concentration Humira biosimilar to obtain permission from EMA, characterized by halving drug administration compared to low concentrations and removing citrate that can cause pain.

 

An official from Celltrion said, "We believe that if Yuflyma secures its interchangeable biosimilar status through interchangeable clinical trials, it will greatly help expand its market share by strengthening its competitiveness." "High-quality bio at reasonable prices for global markets, including in Korea, while making every effort to prepare for clinical and licensing, and we will do our best to proceed with the supply of medicines."