Denosumab biosimilar is under clinical development by Sandoz International and currently in Pre-Registration for Post Menopausal Osteoporosis. According to GlobalData, Pre-Registration drugs for Post Menopausal Osteoporosis have a 67% 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 (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 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.


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.