Ustekinumab biosimilar is under clinical development by BioFactura and currently in Phase I for Psoriasis. According to GlobalData, Phase I drugs for Psoriasis have a 78% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Ustekinumab biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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.

For a complete picture of Ustekinumab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.


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.