DMB-3115 Biosimilar Is Comparable to Ustekinumab in Psoriasis

The ustekinumab (Stelara; Janssen Biotech) biosimilar DMB-3115 (Imuldosa; Accord BioPharma) demonstrated clinical efficacy and safety comparable to the reference product through 52 weeks in a recent trial of patients with moderate to severe plaque psoriasis.1

The phase 3, randomized, double-blind, parallel-arm study is published in JAAD International.

The ustekinumab biosimilar DMB-3115 matched reference therapy in efficacy and safety for moderate to severe plaque psoriasis, according to a phase 3 trial. | Image Credit: Shutter2U - stock.adobe.com

“DMB-3115 has been extensively characterized and compared with ustekinumab, demonstrating similar safety, tolerability, and immunogenicity in healthy participants,” wrote the researchers of the study. “The primary objective of the current study was to evaluate the clinical similarity and compare efficacy, safety, and immunogenicity of DMB-3115 with ustekinumab in patients with moderate to severe chronic plaque psoriasis.”

Without insurance in the US, ustekinumab is among the most expensive biologic therapies, with the average retail cash price for a single 45-mg prefilled syringe exceeding $22,000 and a 90-mg syringe often costing nearly $39,000 per dose, according to GoodRx. These high list prices reflect the complexity and cost of developing and manufacturing biologic medicines, but they can translate into annual out-of-pocket costs well over 6 figures if multiple doses are needed without coverage. However, most patients do not pay the full cash price, and many health plans cover ustekinumab with prior authorization or step therapy requirements, while manufacturer copay savings programs or patient assistance programs can significantly reduce out-of-pocket costs for commercially insured or eligible uninsured patients.

In January 2024, the FDA accepted Accord BioPharma’s biologic license application for DMB-3115, supported by data demonstrating similarity to the reference product in quality, safety, and efficacy, including results from a phase 3 plaque psoriasis study.3

The study enrolled adults with moderate to severe plaque psoriasis who were assigned 1:1 to receive either the ustekinumab biosimilar DMB-3115 or reference ustekinumab from weeks 0 to 28.1 At week 28, patients were rerandomized to either continue their assigned treatment or switch to DMB-3115 through week 52 to assess the impact of treatment switching. The primary efficacy end points were the percent change from baseline in Psoriasis Area and Severity Index score at weeks 8 and 12, while safety was evaluated by monitoring the incidence of adverse events throughout the study period.

Among 598 randomized patients, 299 received DMB-3115 and 299 received reference ustekinumab. The least squares (LS) mean percent reduction in PASI scores was 77.5% with DMB-3115 and 77.9% with ustekinumab at week 8, increasing to 87.6% and 87.9%, respectively, by week 12. Safety outcomes were also comparable, with treatment-emergent adverse events reported in 47.5% of patients receiving DMB-3115 and 49.8% of those receiving ustekinumab during period 1, and in 18.7% of patients continuing DMB-3115, 21.2% continuing ustekinumab, and 18.3% of those who switched to DMB-3115 during period 2.

The researchers believe the findings support DMB-3115 as a clinically similar alternative to reference ustekinumab, demonstrating comparable efficacy and safety in adults with moderate to severe plaque psoriasis through 52 weeks. These results suggest DMB-3115 may offer a viable biosimilar option that could expand treatment choice and potentially improve access to biologic therapy.

“This study demonstrated equivalent efficacy between DMB-3115 and ustekinumab, as shown by the similar LS mean percent changes in PASI score from baseline,” wrote the researchers. “Both treatments provided improved efficacy in patients with moderate to severe plaque psoriasis with no clinically meaningful differences in efficacy and safety.”

References

1. Vekovska K, Imko-Walczuk B, Tichý M, et al. A randomized, double-blind, phase 3 study to compare efficacy, safety, and immunogenicity between DMB-3115 and reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. JAAD Int. 2025;24:147-165. doi:10.1016/j.jdin.2025.09.004

2. Woodcock S. How much is Stelara without insurance? GoodRx. October 24, 2025. Accessed December 15, 2025. https://www.goodrx.com/stelara/how-much-stelara-costs-without-insurance?srsltid=AfmBOoo3IFjLyZnI_Q9sP2sSG7fvzQC65HGe_I_rcUTYXyXyazA-ecp2

3. Accord BioPharma, Inc. announces US FDA acceptance of Biologics License Application for proposed Stelara biosimilar DMB-3115. News release. Accord BioPharma. January 4, 2024. Accessed December 15, 2025. https://www.prnewswire.com/news-releases/accord-biopharma-inc-announces-us-fda-acceptance-of-biologics-license-application-for-proposed-stelara-biosimilar-dmb-3115-302025983.html