Number 3: Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its ...
Patients who discontinue treatment with the osteoporosis drug denosumab, despite transitioning to zoledronate, show significant losses in lumbar spine bone mineral density (BMD) within a year ...
Denosumab treatment for osteoporosis raises the risk for hypocalcemia, which worsens with advancing stages of chronic kidney disease (CKD), in those with CKD–Mineral and Bone Disorder (CKD-MBD ...
Researchers assessed the therapeutic equivalence of proposed biosimilar CT-P41 and reference denosumab for the treatment of postmenopausal osteoporosis.
Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat ...
FDA’s boxed warning on denosumab follows study results showing increased and early risks of severe hypocalcemia in patients on dialysis. The Food and Drug Administration (FDA) has added a new ...
TUESDAY, Nov. 19, 2024 (HealthDay News) -- For patients with chronic kidney disease (CKD), the risk for emergently treated hypocalcemia with denosumab increases with worsening CKD stage ...
Sandoz has claimed the first FDA approvals for biosimilars of Amgen’s blockbuster bone disease therapy denosumab, but has not said when it plans to launch them onto the US market. Amgen sells ...
Worsening CKD was progressively associated with denosumab-induced hypocalcemia warranting emergency treatment. Denosumab use carries a higher risk for emergency hypocalcemia compared with ...
GlycoNex developing denosumab biosimilar, SPD8, for the treatment of osteoporosis NEW TAIPEI CITY, Taiwan, Dec. 17, 2024 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter ...
The researchers found that with denosumab versus oral bisphosphonates, the risk for emergently treated hypocalcemia increased with worsening CKD stage, with the highest risk seen among dialysis ...