Denosumab

Generic Name: Denosumab

Brand Names: Prolia, Xgeva, Wyost, Jubbonti

Drug Type: Biotech

Chemical Formula: -

CAS Number: 615258-40-7

Unique Ingredient Identifier: 4EQZ6YO2HI

Background: Denosumab is a novel, fully human IgG2 monoclonal antibody specific to receptor activator of nuclear factor kappa-B ligand (RANKL), suppresses bone resorption markers in patients with a variety of metastatic tumors and is being investigated in multiple clinical trials for the prevention and treatment of bone metastases. Chemically, it consists of 2 heavy and...

Indication: Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. It reduces the incidence of vertebral, nonvertebral, and hip fractures. Prolia is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. It can also be use...

Associated Conditions: Bone Fractures, Bone Giant Cell Tumor, Bone Loss, Bone pain, Spinal Cord Compression, Bone destruction, High risk of fracture Osteoporosis, Refractory Hypercalcemia of malignancy

Associated Therapies: -

Clinical Trials

Review Confirms Clinical Safety of Sandoz Denosumab Biosimilar vs Originator

Sandoz's biosimilar denosumab (Jubbonti/Wyost) demonstrated analytical, PK, PD, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting FDA approval and extrapolation to all indications. Approved in March 2024 for osteoporosis and bone metastases, Jubbonti/Wyost offers an affordable alternative, with comprehensive analytical and clinical evaluations confirming high similarity and equivalence.

hcplive.com

2 months ago

FDA Accepts BLA for Denosumab Biosimilar

The FDA accepted Organon and Shanghai Henlius Biotech's BLA for HLX14, a denosumab biosimilar. HLX14 is intended for osteoporosis and bone mass increase in various patient groups. The BLA is supported by comparative quality and clinical studies. Organon has exclusive commercialization rights in the US, EU, and Canada. The FDA approved the first denosumab biosimilars, Wyost and Jubbonti, in March 2024.

Drug Development Updates

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