Ustekinumab biosimilar is under clinical development by Bio-Thera Solutions and currently in Pre-Registration for Plaque Psoriasis (Psoriasis Vulgaris). According to GlobalData, Pre-Registration drugs for Plaque Psoriasis (Psoriasis Vulgaris) have a 90% 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 is a human monoclonal antibody acts as an immunosuppressant agent. It is produced by a recombinant DNA technology. It is formulated as solution for subcutaneous route of adminsitration. It is indicated for the treatment of active psoriatic arthritis (PsA) in adults, alone or in combination with methotrexate; for the treatment of patients 6 years or older with moderate to severe plaque psoriasis who have not responded, or who are intolerant to other systemic therapies, including cyclosporine, methotrexate and ultraviolet A radiation associated with psoralen administration ( PUVA ), for the treatment of adult patients with moderate to severe active Crohn's disease and ulcerative colitis, who have had an inadequate response, loss of response to conventional therapy or anti-TNF-alpha.
Ustekinumab biosimilar (BAT-2206) is under development for the treatment of plaque psoriasis (psoriasis vulgaris), psoriatic arthritis, Crohn's Disease and ulcerative colitis. The drug candidate acts by targeting interleukin 12 subunit beta and interleukin 23 subunit alpha. It is administered through subcutaneous route.
Bio-Thera Solutions overview
Bio-Thera Solutions (Bio-Thera) is a biopharmaceutical company that specializes in researching and developing novel therapeutics. It primarily focuses on the treatment of cancer, autoimmune, cardiovascular and eye diseases, and other severe unmet medical needs. The company offers products that include qletli, pobevcy, tofidence, and betagrin. Its pipeline products include humanized monoclonal antibodies and peptide drugs such as BAT8001, BAT8003, BAT1306, BAT2094, and BAT4306F. Bio-Thera’s products are used in the treatment of various diseases, with applications in the medical and healthcare industries. The company also develops biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. It operates in China and the US. Bio-Thera is headquartered in Guangzhou, Guangdong, China.
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.
