Denosumab biosimilar is under clinical development by Lupin 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 is under development for the treatment of bone metastasis, giant cell tumor of bone, post menopausal osteoporosis in women with non metastatic breast cancer who are having low bone mass and to increase bone mass in men with non metastatic prostate cancer and who are at high risk for fracture. The drug candidate is administered by subcutaneous route. It acts by targeting RANKL.

Lupin overview

Lupin develops and manufactures generic and branded formulations, biotechnology products, and active pharmaceutical ingredients (APIs). It has expertise in the areas of cardiovascular, asthma, diabetic management, pediatrics, central nervous system, gastro-intestinal, anti-infectives, nonsteroidal anti-inflammatory drugs (NSAIDs), anti-TB, and cephalosporins. The company undertakes extensive research and development activities of pharmaceuticals for the treatment of migraine, gastrointestinal, psoriasis, central nervous system, cardiovascular, diabetes, tuberculosis, inflammation and others. Lupin also develops value-added generic pharmaceuticals based on its platform technologies. The company along with its subsidiaries operates manufacturing facilities in India, the US, Mexico, and Brazil. Lupin is headquartered in Mumbai, Maharashtra, India.

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

This content was updated on 7 February 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.