FDA Accepts Biologics License Application for Ustekinumab Biosimilar DMB-3115


BLA submission was based on data from phase 3 clinical trials in which DMB-3115 showed no clinically meaningful differences compared with the reference product for the treatment of plaque psoriasis.

FDA Accepts Biologics License Application for Ustekinumab Biosimilar DMB-3115

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has accepted the biologics license application (BLA) for the proposed ustekinumab (STELARA) biosimilar DMB-3115, according to a statement released by Accord BioPharma.1 The reference product is currently used to treat psoriatic arthritis, plaque psoriasis, ulcerative colitis, and Crohn’s disease.

“The ability of DMB-3115’s reference product, STELARA, to treat autoimmune diseases is well established and we’re excited to take this important step toward providing patients a more accessible avenue to treatment for conditions that present such a significant disease burden,” Chrys Kokino, US president of Accord, said in a statement.1

The submission for the BLA was based on data from phase 3 multiregional clinical trials in which adult patients with plaque psoriasis received a subcutaneous dose of 45 mg or 90 mg DMB-3115 or ustekinumab.2 The primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for symptoms related to the skin. Results showed no clinically meaningful differences regarding safety, efficacy, and quality of the biosimilar compared with ustekinumab.

“Our mission to go beyond the biology of medicine includes seeking to ease the financial burden for patients and the U.S. healthcare system by providing medicines that may be more affordable, such as biosimilars,” Kokino stated.1

The proposed launch date for the biosimilar will be no later than May 15, 2025. Accord BioPharma has also submitted 3 additional BLAs to the FDA for biosimilar versions of trastuzumab, pegfilgrastim, and filgrastim, and is planning to release several more biosimilars to the US market within the next 5 years.


  1. BioPharma, A. (2024, January 4). Accord BioPharma, Inc.. announces U.S. FDA acceptance of Biologics License Application For proposed STELARA® Biosimilar DMB-3115. PR Newswire: press release distribution, targeting, monitoring and marketing. 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?tc=eml_cleartime
  2. Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis (Opportuniti). CTG Labs - NCBI. (n.d.). https://clinicaltrials.gov/study/NCT04785326#study-overview
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