Denosumab biosimilar is under clinical development by Aurobindo Pharma 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 postmenopausal osteoporosis. It is administered through subcutaneous route. The therapeutic candidate acts by targeting RANK ligand (RANKL).

Aurobindo Pharma overview

Aurobindo Pharma (Aurobindo) is a vertically integrated pharmaceutical company that manufactures and markets generic pharmaceuticals and active pharmaceutical ingredients (APIs). Its product portfolio is spread across major therapeutic and product categories including antibiotics, anti-retroviral, systemic gastroenterological, central nervous system, cardiovascular, anti-allergies, anti-diabetics, other therapeutic areas. The company also produces novel proprietary biocatalysts, vitamins, minerals, dietary supplements, sports nutrition, functional foods, weight loss products and fermentation-based semi-synthetic products. Aurobindo operates manufacturing facilities in India, Brazil, Portugal and the US; and R&D facilities in India and the US. The company exports products to several countries worldwide. Aurobindo is headquartered in Hyderabad, Telangana, India.

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

This content was updated on 10 June 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.