Denosumab biosimilar is under clinical development by Sandoz Group and currently in Phase III for Bone Metastasis. According to GlobalData, Phase III drugs for Bone Metastasis have a 67% 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.
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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 (Jubbonti, Wyost), is a human IgG2 monoclonal antibody. It is formulated as solution for subcutaneous route of administration. It is indicated for the treatment of postmenopausal osteoporosis, also indicated to increase bone mass in men with osteoporosis at high risk for fracture, increase bone mass in men with nonmetastatic prostate cancer receiving androgen deprivation therapy (adt), who are at high risk for fracture, increase bone mass in women receiving adjuvant aromatase inhibitor therapy for nonmetastatic breast cancer and increase bone mass for the treatment and prevention of glucocorticoid induced osteoporosis in women and men at high risk for fracture, chemotherapy effects, glucocorticoid-induced osteoporosis, osteoporosis.
Sandoz Group overview
Sandoz Group develops, manufactures and distributes generics and biosimilar medical products used for the treatment of various life threatening diseases. The company is headquartered in Zug City, Zug, Switzerland.
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.
