Celltrion's 'Uplima' Successfully Secures Interchangeability

Celltrion announced on the 26th that equivalence between the biosimilar for autoimmune disease treatment 'Yuflyma (generic name Adalimumab, development code CT-P17)' and the original drug 'Humira' was demonstrated in the global Phase 3 clinical trial for securing interchangeability between the two drugs.

Biosimilar of the autoimmune disease treatment Humira, 'Yuflyma' US product.
[Photo by Celltrion]

In this Phase 3 trial involving 367 patients with moderate to severe plaque psoriasis, Celltrion compared and verified pharmacokinetics, efficacy, and safety between the multiple-switch dosing group of Yuflyma and Humira and the Humira maintenance dosing group. As a result, the primary pharmacokinetic evaluation variables for interchangeability approval, 'area under the curve and maximum serum concentration at weeks 25 to 27,' were found to be within the predefined equivalence margin range (80?125%), confirming equivalence. Similar results were also confirmed in secondary endpoints evaluating pharmacokinetics, efficacy, and safety between the two dosing groups.

Based on these clinical results, Celltrion plans to initiate the U.S. Food and Drug Administration (FDA) interchangeability approval process to secure the status of a biosimilar interchangeable with the original drug.

The importance of proving interchangeability stems from the nature of biopharmaceuticals. Due to their biologic origin, biopharmaceuticals cannot be perfectly replicated like synthetic drugs but only similarly replicated. This is why biosimilars have distinct generic names such as 'Adalimumab-aaty (Yuflyma)' and 'Adalimumab-bwwd (Samsung Bioepis's Hadlima).' Consequently, unlike generic synthetic drugs, biosimilars are generally not allowed to be substituted at pharmacies in the U.S.

However, once interchangeability is proven, prescribing physicians are more incentivized to cross-prescribe Yuflyma, which has the same efficacy and safety, and pharmacists can autonomously dispense interchangeable biosimilars even if the original drug was prescribed, enabling increased market share. This is especially significant in the Adalimumab market, where patients receive prescriptions at pharmacies and self-administer injections or pens at home, making interchangeability even more meaningful.

Humira is a blockbuster autoimmune disease treatment drug, generating sales of $21.237 billion (approximately KRW 27.6 trillion) as of last year. Notably, in the U.S. market, considered the largest market, it recorded sales of $18.619 billion (approximately KRW 24.2 trillion), accounting for over 87% of global sales.

Previously, Celltrion confirmed similar efficacy, pharmacokinetics, and safety results for Yuflyma compared to Humira through a global Phase 3 clinical trial involving rheumatoid arthritis (RA) patients. Based on this trial, Celltrion obtained marketing authorization from the European Medicines Agency (EMA) and the FDA for all indications held by Humira, including rheumatoid arthritis, inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis, and psoriasis (PS), and is supplying Yuflyma accordingly.

Yuflyma is the first high-concentration Humira biosimilar, characterized by halving the drug dosage compared to low concentration and removing citrate, which can cause pain. Celltrion plans to strengthen its market position by securing differentiation in dosage and formulation. In September, Celltrion additionally obtained FDA approval for Yuflyma's 80 mg/0.8 mL and 20 mg/0.2 mL dosage forms, completing a lineup of three high-concentration Adalimumab products including the existing 40 mg/0.4 mL formulation.

A Celltrion official stated, “Based on the results of this global Phase 3 clinical trial, we plan to accelerate the approval process to secure the status of a high-concentration interchangeable biosimilar. We will continue to strengthen competitiveness and rapidly expand market share through consistent product differentiation strategies.”

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