Celltrion announced Thursday that the results of its global phase 3 study evaluating the interchangeability between Yuflyma (ingredient: adalimumab), the company’s high-concentration Humira biosimilar, and the reference product Humira, have been published in the SCIE-indexed international journal Dermatology and Therapy.

The originator drug Humira, developed by AbbVie, generated approximately $8.99 billion in global sales in 2024, with more than 79 percent—$7.14 billion—coming from the U.S. market alone.

Yuflyma is a high-concentration, citrate-free formulation of adalimumab developed by Celltrion. Compared to the original low-concentration version, it offers the same therapeutic effect with a reduced injection volume, and improved patient comfort by eliminating citrate, a common source of injection-site pain.

The company currently supplies Yuflyma in three strengths—20mg/0.2ml, 40mg/0.4ml, and 80mg/0.8ml—across global markets. Celltrion has implemented tailored tender strategies in key European countries to grow its market share, while leveraging a dual pricing model in the U.S. to expand its distribution channels.

The newly published paper details the findings of an open-label extension study that followed a 27-week double-blind clinical trial comparing the interchangeability of Yuflyma and Humira in patients with moderate to severe plaque psoriasis.

The extension study, conducted through week 52, involved all patients receiving Yuflyma monotherapy regardless of their previous treatment group.

In the initial 27-week study, Celltrion enrolled 367 patients and divided them into two groups: one receiving multiple switches between Humira and Yuflyma, and another maintained on Humira. The trial compared the pharmacokinetics (PK), efficacy, safety, and immunogenicity between the two groups. The results demonstrated statistical equivalence in PK and confirmed comparable efficacy, safety, and immunogenicity.

From week 27 to week 52, all patients transitioned to Yuflyma. During the open-label extension period, Celltrion observed consistent results across all key endpoints, regardless of prior treatment. The PK, efficacy, safety, and immunogenicity profiles remained stable and similar between the previous groups, supporting the sustained therapeutic performance of Yuflyma.

Following these results, Celltrion has actively presented its interchangeability data at major international conferences, including the 2024 European Academy of Dermatology and Venereology (EADV), the 2024 Fall Clinical Dermatology Conference (FCDC), and the upcoming 2025 American Academy of Dermatology (AAD) meeting.

The company aims to reaffirm Yuflyma’s competitive edge over the originator drug through continued scientific dissemination.

In January 2024, Celltrion submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA, seeking an interchangeability designation for Yuflyma with Humira. If granted, the status would allow pharmacy-level substitution without requiring prescriber approval, which the company believes could significantly increase trust and adoption of the biosimilar in the U.S. market.

“Given the U.S. prescription system is based on active ingredient names rather than brand names, demonstrating clinical interchangeability is key to increasing Yuflyma’s market share,” a Celltrion official said. “We anticipate that securing this designation will further solidify our presence in the world’s largest pharmaceutical market.”

As the results of Yuflyma’s interchangeability study continue to be published in prestigious international journals, the company is reaffirming the product’s global competitiveness, particularly in the U.S., he added.

The official stressed that the company will continue to pursue country-specific strategies to ensure sustained growth in global market share.