欧盟人用医药产品委员会 (CHMP)对Celltrion的三种候选生物仿制药——Eydenzelt® (aflibercept)、Stoboclo®和Osenvelt® (denosumab)以及Avtozma® (tocilizumab)给出积极意见 ...

Denosumab biosimilar is under clinical development by Samsung Bioepis and currently in Phase III for Post Menopausal Osteoporosis.

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 ...

On this episode of Not So Different, we reflect on 2024 and this show in particular, taking audiences back through the most ...

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 ...

In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first ...

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

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 ...

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 ...

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 ...