Celltrion said Tuesday it confirmed interchangeability between Yuflyma (adalimumab), an autoimmune disease biosimilar, and the original drug AbbVie’s Humira,  in a global phase 3 psoriasis clinical trial.

Based on the clinical results, Celltrion plans to get approval from the U.S. FDA for the interchangeability between Yuflyma and Humira.


(Credit: Celltrion)
Yuflyma is a highly concentrated Humira biosimilar that halves the drug dose and eliminates citrate, which can cause pain.

Humira is a blockbuster autoimmune disease drug that generated sales of approximately $21.2 billion last year. In the U.S. alone, the largest market, Humira generated approximately $18.7 billion in sales, more than 87 percent of global sales.

The trial compared 367 patients with moderate-to-severe plaque psoriasis who received alternating doses of Yuflyma and Humira to those who received Humira alone.

The results demonstrated equivalence between the two treatment arms and confirmed similar results in pharmacokinetics, efficacy, and safety, Celltrion said. 

Interchangeability will allow patients taking the original drug to cross-prescribe Yuflyma with the same efficacy and safety. It is also expected to accelerate Yuflyma's market penetration as pharmacies can substitute Yuflyma for Humira.

"Based on the results of this global phase 3 study, we plan to accelerate the approval process to secure our high-concentration biosimilar's status, a Celltrion official said. “We will continue to pursue our product differentiation strategy to strengthen our competitive position in the market and rapidly expand our share."

Source:- Korea Biomed