Amgen sells RANKL inhibitor denosumab as Prolia for osteoporosis in women and men and bone loss caused by other drug treatments, while Xgeva is used for a range of cancer indications, including ...

1 Denosumab is a monoclonal antibody that blocks the receptor activator of the nuclear factor kappa-B ligand (RANKL) protein that is responsible for bone breakdown. 6 By stopping bone loss, it helps ...

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 ...

Clinical studies confirmed equivalent efficacy, safety, and pharmacokinetics between denosumab biosimilars and reference products. Common adverse events for Ospomyv include back pain and ...

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 ...

OSPOMYV™ (denosumab-dssb) injection, for subcutaneous use Ospomyv is a RANK ligand (RANKL) inhibitor indicated for treatment: SELECTED SAFETY INFORMATION CONTRAINDICATIONS These highlights do ...

First approved in 2010, RANK ligand (RANKL) inhibitor Prolia remains an important drug for Amgen. The company recorded sales of $3.25 billion for the drug last year, two thirds from the US market.

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The approvals are based on a comprehensive clinical data package, which included a phase 1 trial (NCT04621318) comparing denosumab-dssb to the reference product (European Union sourced and United ...

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 ...

The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on ...