Celltrion said that it has presented the phase 3 clinical trial results of Yuflyma, a new biosimilar of Abbvie's blockbuster drug, Humira (Ingredient: Adalimumab), during the 2021 European Congress of Rheumatology.

The company conducted the phase 3 clinical trials for 52 weeks and evaluated the overall safety, including efficacy, pharmacokinetic, and immunogenicity of Yuflyma.

Celltrion confirmed similar efficacy, pharmacokinetics, and safety results for one year in all three groups, including the Yuflyma.-treated group, the Humira-administered group, and the Yuflyma replacement group 26 weeks after Humira administration.

There was no significant difference between the three groups in the increase of immunogenicity due to antibody production after replacement dosing, Celltrion said

"Through the presentation in Europe, we demonstrated the efficacy and safety of Yuflyma, the world's first high-concentration formulation of Humira biosimilar," a company official said. "By quickly supplying Yuflyma with differentiated competitiveness to European medical professionals and patients waiting for a high-concentration Humira biosimilar, we will provide high-quality biopharmaceuticals at a reasonable price."

Celltrion obtained approval from the European Commission (EC) to sell Yuflyma for all indications of Humira, including rheumatoid arthritis, inflammatory bowel disease, and psoriasis, in February. Celltrion Healthcare, a separate unit responsible for global marketing and distribution, is speeding up Yuflyma's early entry into the European market.

According to Celltrion, the size of the European adalimumab market is about 4.5 trillion won ($4 billion). Since Abbvie, an original drug developer, obtained European approval for a high-concentration Humira formulation in 2015, more than 90 percent of Humira sold in Europe was a high concentration formulation.