Denosumab biosimilar is under clinical development by Sandoz International and currently in Pre-Registration for Glucocorticoid-Induced Osteoporosis. According to GlobalData, Pre-Registration drugs for Glucocorticoid-Induced Osteoporosis does not have sufficient historical data to build an indication benchmark PTSR for Pre-Registration. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Denosumab biosimilar LoA Report. 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 (GP-2411) is under development for the treatment of postmenopausal osteoporosis, treatment-induced bone loss, metastases to bone, giant cell tumor of bone. It is administered through subcutaneous route as an injection. The drug candidate acts by targeting the receptor activator of nuclear factor kappa B ligand (RANKL).

Sandoz International overview

Sandoz International (Sandoz), a subsidiary of Novartis AG develops, manufactures and commercializes generic pharmaceutical products. The company provides biosimilars, generic antibiotics, dermatology and transplantation medicines. Its biosimilars comprise Omnitrope, Binocrit and Zarzio products. Sandoz offers products for oncology, central nervous system (CNS), respiratory, pain and ophthalmology. It offers products in the form of creams and gels, tablets, orodispersible films, transdermal patches, implants and inhalers. The company sells its products through a network of distributors in Germany and abroad. It has a presence in Austria, Italy, Russia, the UK, France, Canada, the US, and Belgium among others. Sandoz is headquartered in Holzkirchen, Germany.

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

This content was updated on 2 September 2023

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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.