Business-Biosimilars-DenOsteoRel

DenOsteoRel™ (Denosumab) is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.

DenOsteoRel™ (Denosumab) is a sterile, preservative-free, clear, colorless to pale yellow solution available as a 1 mL single-use vial and a single-dose prefilled syringe that contains 60 mg of denosumab (60 mg/mL solution).

DenOsteoRel™ (Denosumab) is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.