The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.

The likelihood of achieving target T-scores at the total hip and lumbar spine with denosumab depends on baseline BMD in postmenopausal women with osteoporosis.

The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, ...

The biosimilar approval was based on a comprehensive clinical data package, which included a double-blind, randomized, active-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT04757376) that ...

“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...

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

The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.

The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and ...

Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA® ...

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 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 ...

The FDA has approved Stoboclo (denosumab-bmwo), a biosimilar to Prolia (denosumab), and Osenvelt (denosumab-bmwo), a biosimilar to Xgeva (denosumab).