Celltrion Presents Study Proving Interchangeability of 'Yuflyma' at European Conference

Celltrion announced on the 26th that it has revealed the results of the global Phase 3 clinical trial on the interchangeability between the autoimmune disease treatment drug Uplyma and Humira at the 2024 European Academy of Dermatology and Venereology (EADV).

Humira biosimilar 'Yuflyma' developed by Celltrion [Photo by Celltrion]

EADV is a prestigious dermatology conference where global experts influential in fields such as psoriasis and skin cancer gather to share the latest industry technologies, networking opportunities, and advanced treatment strategies. This year marks its 33rd session. It is held over four days from the 25th to the 28th in Amsterdam, Netherlands.

At this conference, Celltrion disclosed for the first time the results of the global Phase 3 clinical trial on the interchangeability between Uplyma and Humira conducted on 367 patients with moderate to severe plaque psoriasis. The results confirmed that the pharmacokinetic characteristics between the multiple crossover dosing group of Uplyma and Humira and the Humira maintenance dosing group met the statistical equivalence criteria. Similarities were also observed in safety, immunogenicity, and efficacy.

Based on these clinical results, Celltrion has already submitted a supplemental approval application to the U.S. Food and Drug Administration (FDA) earlier this year to secure interchangeability status between Uplyma and Humira. Securing interchangeability status is expected to increase user confidence in cross-prescription. Additionally, under the U.S. prescription system where prescriptions are issued by generic name rather than brand name, pharmacists’ discretion or patient demand will allow product selection, which is anticipated to positively impact market share expansion in the U.S. based on product competitiveness.

Uplyma is Celltrion’s first high-concentration biosimilar drug to Humira. Compared to the low concentration version, it halves the drug dosage and removes citrate, which can cause pain. Based on a dual pricing policy where the same product is priced differently as a high-cost version (monthly dosing cost $6,577 (approx. 8.75 million KRW)) and a low-cost version (monthly $1,038 (approx. 1.38 million KRW)), Celltrion has signed listing contracts with the three major Pharmacy Benefit Managers (PBMs) that influence about 80% of the U.S. insurance market and expanded supply channels, entering a full-scale growth phase with aggressive marketing strategies.

The original drug of Uplyma, Humira, recorded global sales of $14.04 billion (approx. 19 trillion KRW) last year, making it a global blockbuster product. Of this, more than 84%, $12.16 billion (approx. 16 trillion KRW), was sold in the United States, the world’s largest pharmaceutical market.

A Celltrion official stated, “Uplyma, which is showing growth in major countries worldwide, confirmed pharmacokinetic equivalence as well as similarity in efficacy and safety with the original drug in the Phase 3 interchangeability clinical trial, and we were able to present the clinical results at a prestigious conference. As a favorable atmosphere for biosimilars spreads in the global market, we will focus more on marketing based on Uplyma’s differentiated competitiveness to rapidly expand market share.”

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