Denosumab biosimilar is under clinical development by Fresenius Kabi SwissBioSim and currently in Pre-Registration for Osteoporosis. According to GlobalData, Pre-Registration drugs for Osteoporosis have a 64% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. 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 (FKS518) is under development for the treatment of post menopausal osteoporosis, glucocorticoid-induced osteoporosis, to increase bone mass in men and women at high risk for fracture, increase bone mass in men with osteoporosis, prevention of skeletal-related events in cancer patients, adults and skeletally mature adolescents with giant cell tumor of bone and hypercalcemia. It is administered through subcutaneous route as solution. The therapeutic candidate is a monoclonal antibody acts by targeting receptor activator of nuclear factor kappa B ligand (RANKL).

Fresenius Kabi SwissBioSim overview

Fresenius Kabi SwissBioSim, a subsidiary of Fresenius Kabi AG, is a biopharmaceutical company that develops novel therapeutics for treating autoimmune disease and oncology. The company is headquartered in Eysins, Waadt, 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.