Ustekinumab biosimilar is under clinical development by Samsung Bioepis and currently in Phase III for Plaque Psoriasis (Psoriasis Vulgaris). According to GlobalData, Phase III drugs for Plaque Psoriasis (Psoriasis Vulgaris) have an 81% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. 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 (SB17) is under development for the treatment of autoimmune disorders including plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. It is administered through subcutaneous route. The drug candidate is monoclonal antibody that acts by targeting interleukin 12 subunit beta and interleukin 23 subunit alpha. 

Samsung Bioepis overview

Samsung Bioepis, a subsidiary of Samsung Biologics Co Ltd, is a biopharmaceutical company. The company develops biosimilar products for immunology, oncology, ophthalmology, hematology and endocrinology indications. It offers biologic drugs for the treatment of Crohn’s disease, ulcerative colitis, psoriasis, cancer and arthritis. The company is investigating SB12, an Eculizumab biosimilar targeting paroxysmal nocturnal hemoglobinuria; SB15, an Aflibercept biosimilar medicine against neovascular age-related macular degeneration; SB16, a denosumab biosimilar for the treatment of endocrinology disorders. Samsung Bioepis is also evaluating SB17, a Ustekinumab molecule against moderate to severe plaque psoriasis; and SB26 biosimilar to treat gastroenterology indications. It operates as a joint venture between Samsung Biologics Co Ltd and Biogen Therapeutics Inc. Samsung Bioepis is headquartered in Incheon, Seoul, South Korea.

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.