Denosumab biosimilar is under clinical development by Shanghai Henlius Biotech 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 (HLX-14) is under development for the treatment of giant cell tumor, bone metastases and postmenopausal women with osteoporosis at high risk for fracture. The drug candidate is a humanized monoclonal antibody. It is administered through subcutaneous route. The drug candidate acts by targeting receptor activator of nuclear factor kappa B ligand (RANKL).

Shanghai Henlius Biotech overview

Shanghai Henlius Biotech (Henlius), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co Ltd, is a biopharmaceutical company, which includes research, development, production and marketing of monoclonal antibody products. It develops medicine for oncology, autoimmune and ophthalmic diseases. The company offers products such as rituximab injection for treating chronic lymphocytic leukemia and non-Hodgkin lymphoma; trastuzumab for breast cancer, metastatic gastric cancer and metastatic breast cancer; and adalimumab injection for ankylosing spondylitis, rheumatoid arthritis, plaque psoriasis and uveitis. It also offers bevacizumab injection and serplulimab injection. The company operates research and development centers in Shanghai, China and the US. Henlius is headquartered in Shanghai, China.

For a complete picture of Denosumab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 May 2024

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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.