Ustekinumab biosimilar is under clinical development by Celltrion and currently in Pre-Registration for Crohn’s Disease (Regional Enteritis). According to GlobalData, Pre-Registration drugs for Crohn’s Disease (Regional Enteritis) have a 95% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. 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 (Steqeyma) is a human monoclonal antibody used as immunosuppressant. It is formulated as solution in pre-filled syringe for subcutaneous and intravenous route of administration. Steqeyma is indicated for the treatment of Crohn's disease (regional enteritis), plaque psoriasis (psoriasis vulgaris), psoriatic arthritis and ulcerative colitis.
Ustekinumab biosimilar (CTP-43) is under development for the treatment of plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease. It is administered through subcutaneous route in the form of solution. The drug candidate acts by targeting interleukin 12 subunit beta and interleukin 23 subunit alpha.
Celltrion overview
Celltrion is a biopharmaceutical company that focuses on the research, development, and manufacture of biosimilars and novel biopharmaceuticals. The company offers monoclonal antibodies for the treatment of rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, adult Crohn’s disease, psoriatic arthritis, and psoriasis. Its pipeline portfolio spans monoclonal antibody biosimilars for the treatment of rheumatoid arthritis; colorectal cancer; and respiratory disease; and antibody biologics and vaccines for infectious diseases such as hepatitis B, influenza, rabies, breast cancer, and seasonal influenza. Celltrion develops drugs by using its bioengineering and mammalian cell-culture technology. The company also carries out contract manufacturing of biosimilars. It has an operational presence in Korea, Russia, the UK, and the US. Celltrion is headquartered in Incheon, South Korea.
For a complete picture of Ustekinumab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.
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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
