Ustekinumab biosimilar is under clinical development by Samsung Bioepis and currently in Phase I for Crohn’s Disease (Regional Enteritis). According to GlobalData, Phase I drugs for Crohn’s Disease (Regional Enteritis) have an 82% 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 (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.