Denosumab biosimilar is under clinical development by Celltrion 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.

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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 (Stoboclo, Osenvelt) is a human monoclonal antibody of the immunoglobulin G2 (IgG2), acts as an anti-osteoporotic and antineoplastic agent. It is formulated as solution for subcutaneous route of administration. It is indicated to reduce the risk of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, treatment of giant cell tumors of bone in adults and adolescents with skeletal maturity that are not resectable or for which surgical resection is likely to cause severe morbidity, postmenopausal women with osteoporosis, glucocorticoid-induced osteoporosis, and to increase bone density in male osteoporosis patients, non metastatic prostate cancer receiving androgen deprivation therapy and patients receiving aromatase inhibitor adjuvant therapy.
Denosumab biosimilar is under development for the treatment of post menopausal osteoporosis, osteoporosis and bone loss, prevention  of skeletal complications in adults with advanced  bone malignancies , prevention of skeletal complications due to multiple myeloma and  solid tumor bone metastases and  giant cell tumor of bone. It is administered by subcutaneous route in the form of solution. The therapeutic candidate acts by targeting receptor activator of nuclear factor kappa B ligand (RANKL).

Celltrion overview

Celltrion is a biopharmaceutical company that focuses on the research, development, and manufacture of biosimilars and novel biopharmaceuticals. The company offers monoclonal antibodies for the treatment of rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, adult Crohn’s disease, psoriatic arthritis, and psoriasis. Its pipeline portfolio spans monoclonal antibody biosimilars for the treatment of rheumatoid arthritis; colorectal cancer; and respiratory disease; and antibody biologics and vaccines for infectious diseases such as hepatitis B, influenza, rabies, breast cancer, and seasonal influenza. Celltrion develops drugs by using its bioengineering and mammalian cell-culture technology. The company also carries out contract manufacturing of biosimilars. It has an operational presence in Korea, Russia, the UK, and the US. Celltrion is headquartered in Incheon, South Korea.

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

This content was updated on 12 April 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.