Denosumab biosimilar is under clinical development by Mabxience Holding 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 post menopausal osteoporosis. It is administered subcutaneously as a solution. The therapeutic candidate acts by targeting receptor activator of nuclear factor kappa B ligand (RANKL).

Mabxience Holding overview

Mabxience Holding (mAbxience), a subsidiary of Insud Pharma, is a biotechnology company specialized in the research, development and manufacturing of biosimilar monoclonal antibodies. The company’s products include rituximab, an injection used to treat autoimmune diseases and cancers; bevacizumab, a medication targeting cancers and eye diseases. It also provides contract development and manufacturing services for the production of drug substance and products. mAbxience uses single-use bioreactor technology to manufacture its products in the therapeutic areas of oncology, osteoporosis, rheumatology, psoriasis and pediatrics. The company has research and development centers in Spain and Argentina. mAbxience is headquartered in Madrid, Spain.

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’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.