Request Demo
FDA approves Sandoz’s two denosumab biosimilars
06 Mar 2024
Drug ApprovalOrphan DrugCell TherapyImmunotherapy
The FDA approval positions Wyost as a treatment to prevent skeletal-related events. Credit: BigPixel Photo / Shutterstock.com.
These bFood and Drug Administration (FDA) all indicatioSandozSandoztheWyostfedenosumab-bbdzs.Jubbontidenosumab-bbdzdenosumab
With a concentration of 120mg/1.7mL (70mg/mL), Wyost is indicated as interchangeable with its reference medicine, a human monoclonal antibody that acts on the RANKL protein, which is essential for the activation of osteoclasts.
This approval positions Wyost as a treatment toWyostent skeletal-related events in patients with multiple myeloma and for those with bone metastases caused by RANKL protein.
Wyost is also sanctionedWyostuse in adults and skeletally mature adolescents with giant cell tumomultiple myeloma are either unresectbone metastasesurgical ressolid tumourscause significant morbidity.
Wyostlso:A2 Bio’s cell therapy gains FDA orphan drug status for colorectal cancergiant cell tumours
FDA doublA2 Bion on patient engagemenFDAo support rare disease rcolorectal cancer
It is also approved for treating hypercalcaemia of malignancy resistant to bisphosphonate treatment.
FDAbonti is indicated to address several conditions related to bone health.
It is approved for treating high fracture risk in postmenopausal women with osteoporosis, for improving bone mass in men with osteoporosis at similar risk, and for managing glucocorticoid-induced osteoporosis in anyone with this risk.
Jubbonti is also approved to augmhypercalcaemia of malignancy fracture risk due to undergoing androgen deprivation treatment for non-metastatic prostate cancer, and women receiving adjuvant aromatase inhibitor therapy for breast cancer.
Jubbontie clinical studies support the latest regulatory approval in the US for these biosimilars and include safety warnings within the labelling.
The approval of Jubbonti is pairefracturehe sanctioning of Sandoz’s Jubbontiosteoporosistion and Mitigation Strategy (REMS) prosteoporosisglucocorticoid-induced osteoporosis
Jubbontiramme is tailored to educate prescribers and patients about potential severe hypocalcaemia risk, particularly in those winon-metastatic prostate cancerease, including those dependentaromatasesis.breast cancer
Sandoz North America president Keren Haruvi stated: “Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events […] disease states that can profoundly reduce the quality of life for patients.”
The latest development comes after Sandoz acquired US biosiSandozCIMERLI from Coherus BioSciences.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Indications
Targets
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.