Denosumab biosimilar is under clinical development by Samsung Bioepis and currently in Phase III for Post Menopausal Osteoporosis. According to GlobalData, Phase III drugs for Post Menopausal Osteoporosis have an 83% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Denosumab 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.
Denosumab biosimilar overview
Denosumab biosimilar (SB16) is under development for treatment of osteoporosis and prevention of skeletal related events with advanced malignancies and treatment of giant cell tumour of bone. The therapeutic candidate is a monoclonal antibody, which targets RANK ligand (RANKL). It is administered through subcutaneous route.
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 biological 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. Samsung Bioepis is headquartered in Incheon, Seoul, South Korea.
For a complete picture of Denosumab 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.
