Sandoz Reports the US FDA’s Approval of Wyost and Jubbonti (Biosimilar, Denosumab)

Shots: 

• Sandoz has received the US FDA’s approval for Wyost & Jubbonti (denosumab-bbdz), biosimilars of Xgeva & Prolia (denosumab), based on the clinical studies demonstrating their similarity with the reference drugs 

• The company’s Jubbonti Risk Evaluation & Mitigation Strategy (REMS) program has also been approved to educate HCPs & patients about the severe hypocalcemia risk associated with Jubbonti in advanced CKD, incl. dialysis-dependent patients 

• Wyost is indicated for preventing SREs in MM patients & solid tumor bone metastases, giant cell bone tumor & refractory hypercalcemia while Jubbonti is approved for osteoporosis in postmenopausal women & to increase bone mass associated with certain conditions 

Ref: Sandoz| Image: Sandoz| Press Release

Related News:- Biocon Enters into an Exclusive License Agreement with Bayer and Regeneron for the Commercialization of Yesafili (biosimilar, aflibercept) into the Canadian Market 

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com