Number 3: Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its ...

台康生技(6589)与日商及醣联(4168)三方签订SPD8委托生产协议书，将执行上市前生产计划，三方合作布局日本及国际市场。SPD8是醣联与日商共同开发用于治疗骨质疏松症的Denosumab生物相似性药品，目前已完成临床一期试 ...

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 ...

FDA committee recommends Amgen's denosumab, for the treatment, but not prevention, of bone loss, while Lilly decides not to submit arzoxifene for regulatory review after 5-year trial. Later this ...

Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat ...

Researchers assessed the therapeutic equivalence of proposed biosimilar CT-P41 and reference denosumab for the treatment of postmenopausal osteoporosis.

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 ...

There are four pending BPCIA litigations brought by Amgen against biosimilar companies seeking to market denosumab biosimilars. Two of the four cases are pending in the District Court for the District ...

GlycoNex developing denosumab biosimilar, SPD8, for the treatment of osteoporosis NEW TAIPEI CITY, Taiwan, Dec. 17, 2024 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter ...

Worsening CKD was progressively associated with denosumab-induced hypocalcemia warranting emergency treatment. Denosumab use carries a higher risk for emergency hypocalcemia compared with ...

For patients with chronic kidney disease (CKD), the risk for emergently treated hypocalcemia with denosumab increases with worsening CKD stage, according to a study published online Nov.