Ustekinumab biosimilar is under clinical development by NeuClone and currently in the Phase I in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Ustekinumab biosimilar’s likelihood of approval (LoA) and phase transition for Psoriatic Arthritis took place on 26 Apr 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 26 Apr 2022 increased Ustekinumab biosimilar’s LoA and PTSR for Ulcerative Colitis.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Ustekinumab biosimilar Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Ustekinumab biosimilar overview

Ustekinumab biosimilar is under development for the treatment of active psoriatic arthritis, moderate to severely active Crohn's disease, moderate to severe plaque psoriasis and ulcerative colitis. It is administered through the subcutaneous route. The drug candidate acts by targeting interleukin 12 subunit beta and interleukin 23 subunit alpha. It is developed based on NeuMAX technology.

NeuClone overview

NeuClone is a clinical-stage biopharmaceutical company exclusively developing and commercializing high-quality biosimilar products. They provide services like biosimilars, monoclonal antibodies, biosimilar antibody development in CHO cells, therapeutic antibodies, and biologics. The company is headquartered in Sydney, New South Wales.

Quick View Ustekinumab biosimilar LOA Data

Report Segments
  • Biosimilar
Drug Name
  • Ustekinumab biosimilar
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Gastrointestinal
  • Immunology
  • Musculoskeletal Disorders
Key Developers
  • Sponsor Company: NeuClone
Highest Development Stage
  • Phase I


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.