Celltrion Publishes Phase 3 Clinical Trial Results on Interchangeability of Uplima in International Journal

Smooth Progress in FDA Interchangeability Approval Process
Differentiated Competitiveness Expected Upon Approval

Celltrion autoimmune disease treatment 'Uplima'. Photo by Celltrion

Celltrion announced on the 4th that the results of the global Phase 3 interchangeability clinical trial between the autoimmune disease treatment drug Uplyma (generic name adalimumab) and Humira have been published in the SCIE international journal 'Dermatology and Therapy.'

The study revealed in this paper is the result of an open-label extension study of Uplyma monotherapy extended to 52 weeks, following the 27-week global Phase 3 interchangeability clinical trial between Uplyma and Humira.

Previously, Celltrion conducted a global interchangeability Phase 3 clinical trial of Uplyma on 367 patients with moderate to severe plaque psoriasis. In this trial, patients were divided into two groups: a multiple crossover dosing group between Uplyma and Humira, and a Humira maintenance dosing group. Pharmacokinetics, efficacy, safety, and immunogenicity were compared between the groups over 27 weeks, and the pharmacokinetic characteristics between the two groups met the statistical equivalence criteria. Similarities were also confirmed in efficacy, safety, and immunogenicity.

From week 27 onwards, both the multiple crossover dosing group and the Humira maintenance dosing group received Uplyma monotherapy. During the open-label extension study conducted up to 52 weeks, pharmacokinetics, efficacy, safety, and immunogenicity results were consistently maintained regardless of prior dosing, and similar results were confirmed between the comparison groups.

After securing the interchangeability clinical trial results of Uplyma, Celltrion has repeatedly presented at numerous global conferences such as the '2024 European Academy of Dermatology and Venereology (EADV)', '2024 Fall Clinical Dermatology Conference (FCDC)', and '2025 American Academy of Dermatology (AAD)', as well as in prestigious international journals, reaffirming Uplyma's product competitiveness compared to the original drug.

Based on these clinical results, Celltrion submitted a supplemental application to the U.S. Food and Drug Administration (FDA) in January last year to obtain interchangeability status between Uplyma and Humira. Once interchangeability status is secured, user confidence in cross-prescribing is expected to increase significantly. Especially, given the U.S. prescription system issues prescriptions by generic name rather than product name, the company expects a positive impact on expanding market share in the U.S. based on clinical efficacy and product competitiveness.

Uplyma, developed by Celltrion, is a high-concentration biosimilar of Humira. It features a reduction of the drug dose by half compared to the low concentration version and the removal of citrate, which can cause pain. Currently, it is supplied globally with a lineup of three high-concentration product doses: 20 mg/0.2 ml, 40 mg/0.4 ml, and 80 mg/0.8 ml.

In particular, Uplyma is increasing its market share through tailored bidding strategies in major European countries, and in the U.S., it is expanding distribution channels based on a dual pricing policy, showing growth trends in global sales following the establishment of sales routes.

The original drug of Uplyma, Humira, recorded sales of approximately $8.993 billion (about 12.59 trillion KRW) last year, making it a global blockbuster product. Of this, more than 79% of total sales, approximately $7.142 billion (about 9.998 trillion KRW), were recorded in the U.S., the world's largest pharmaceutical market.

A Celltrion official said, "With the interchangeability clinical trial results of Uplyma being published consecutively in prestigious international journals, we have once again demonstrated product competitiveness in major global countries including the U.S. We will do our best to sustain the upward trend in global market share through tailored strategies for each country."