The study included 2 treatment periods. During the first period, study participants (N=479) were randomly assigned 1:1 to receive denosumab-bmwo or the reference product. Patients who received the ...

Ospomyv and Xbryk, biosimilars to Prolia and Xgeva, received FDA approval for osteoporosis and bone loss treatment. Clinical studies confirmed equivalent efficacy, safety, and pharmacokinetics ...

The FDA approved denosumab-bmwo for all indications of the reference drugs Prolia and Xgeva. According to a settlement between Amgen and Celltrion, the biosimilars can be launched as early as June 1.

Samsung Bioepis received approval for two biosimilars of denosumab that are interchangeable with Prolia and Xgeva. Ospomyv provided similar BMD increases as Prolia for women with osteoporosis in a ...

Osteoporosis is a common bone disease characterized by the progressive loss of bone mass and bone density. Osteoporosis ...

Findings from a phase 3 trial showed denosumab-dssb had comparable efficacy, safety, immunogenicity, PK and PD to Prolia in patients with postmenopausal osteoporosis. Ospomyv is approved to treat ...

Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Prolia (denosumab ...

Taken alongside Prolia/Xgeva, the brands account for well over 40% of Amgen's current revenues. Other companies working on biosimilar versions of denosumab include Samsung Bioepis, Celltrion, and ...

OSPOMYV, referencing Prolia, has been approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, treatment to increase bone mass in men with osteoporosis at ...