Ustekinumab biosimilar is under clinical development by BioFactura 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 Psoriasis took place on 28 Mar 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

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 psoriasis and infectious disease. It is developed based on StableFast biomanufacturing platform. The platform generates stable NS0 cell lines for biopharmaceutical manufacturing. NS0 cell lines produce complex glycoproteins such as monoclonal antibodies. The drug candidate acts by targeting interleukin 12 subunit beta and interleukin 23 subunit alpha. It is administered through subcutaneous route.

BioFactura overview

BioFactura is a manufacturer of biosimilars that discovers, develops and markets biodefense drugs and client selected novel drugs. The company provides contract services such as process development, stable cell lines, manufacturing, and others. Its stable cell line offers stable mammalian cell line development for high titer, scalable manufacture of monoclonal antibodies and recombinant proteins, among others. In addition, Biofactura also provides biodefence products such as smallpox therapeutic, and ebola sudan therapeutic. The company utilizes its stablefast biomanufacturing platform, which is a novel system to generate stable NS0 cell lines for biopharmaceutical manufacturing. It caters biodefense and non-biodefense markets. Biofactura is headquartered in Frederick, Maryland, the US.

Quick View Ustekinumab biosimilar LOA Data

Report Segments
  • Biosimilar
Drug Name
  • Ustekinumab biosimilar
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Immunology
  • Infectious Disease
Key Developers
  • Sponsor Company: BioFactura
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.