Denosumab biosimilar is under clinical development by Luye Pharma Group 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.
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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 (Boyoube), is a human IgG2 monoclonal antibody. It is formulated as solution pre filled syringe for subcutaneous route of administration. Boyoube is indicated in treatment of osteoporosis in postmenopausal women at high risk of fracture, can significantly reduce the risk of vertebral, nonvertebral and hip fractures.
Denosumab biosimilar (LY-06006) is under development for the treatment of postmenopausal osteoporosis and bone fracture. It is administered through subcutaneous route as injection. The drug candidate acts by targeting the receptor activator of nuclear factor kappa B ligand (RANKL).
Luye Pharma Group overview
Luye Pharma Group (Luye Pharma), a subsidiary of Luye Life Sciences Group Ltd, is a drug development company. It discovers, manufactures and commercializes novel formulations, generic drugs and pharmaceutical products. The company offers its products in the form of tablets, formulations for injections, capsules, gels, anti-psychotic medicines and modified-release dosages in the therapeutic areas of oncology, cardiovascular, orthopedics, hepatology, gastroenterology, gynecology, diabetes and central nervous system (CNS). Luye Pharma operates its research and development and manufacturing facilities in the US and China and, among others. Luye Pharma is headquartered in Yantai, Shandong, China.
For a complete picture of Denosumab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.
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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.
