Celltrion Confirms Similarity of Uplima to Original 'Humira' in Phase 3 Clinical Trial

Phase 3 Results Announced at the European Rheumatology Congress

Uplyma (Photo by Celltrion)

[Asia Economy Reporter Kim Ji-hee] Celltrion announced on the 2nd that the Phase 3 clinical trial of Yuflyma, a biosimilar of Humira (active ingredient adalimumab) developed for autoimmune disease treatment, confirmed similar efficacy and safety.

Celltrion presented these results at the European League Against Rheumatism (EULAR), held online from the 2nd to the 5th (local time). The company conducted the Phase 3 trial over 52 weeks, evaluating Yuflyma’s overall safety, including efficacy, pharmacokinetics, and immunogenicity.

As a result, similar efficacy, pharmacokinetics, and safety outcomes were confirmed over one year in all three groups: the Yuflyma administration group, the Humira administration group, and the group switched from Humira to Yuflyma starting at week 26. Additionally, no significant differences were observed among the three groups, including no increase in immunogenicity due to antibody formation after switching. Celltrion explained that this clinical trial demonstrated that patients previously treated with the original drug Humira showed comparable efficacy and safety when treated with Yuflyma.

Yuflyma is the world’s first high-concentration formulation biosimilar of adalimumab to be introduced to the market. It features a reduction of the drug dose by half and the removal of citrate, which can cause pain during injection.

The European adalimumab market size is estimated at 4.5 trillion KRW (based on IQVIA 2020 data). Notably, since AbbVie, the original drug developer, obtained European approval for the high-concentration formulation of Humira in 2015, over 90% of Humira sold in Europe is the high-concentration formulation.

A Celltrion official stated, “Through this conference presentation, we have proven the efficacy and safety of Yuflyma, the first high-concentration formulation product developed as a Humira biosimilar. We plan to rapidly supply Yuflyma, which has differentiated competitiveness, to European medical professionals and patients who have been waiting for a high-concentration Humira biosimilar, thereby continuously providing the benefits of high-quality biopharmaceuticals at a reasonable price.”

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