The new approvals bring the number of denosumab biosimilars in the US to eight, but price reductions are not yet substantial.

The approval was based on a comprehensive clinical data package that included a phase 3 trial comparing denosumab-qbde with Prolia in 473 women with postmenopausal osteoporosis.

DUBLIN--(BUSINESS WIRE)--The "Denosumab (Prolia & Xgeva) Biosimilars Pipeline Review" report has been added to ResearchAndMarkets.com's offering. Denosumab biosimilars, which are currently under ...

The US Food and Drug Administration (:FDA) recently granted approval to Amgen’s (AMGN) Prolia (denosumab) for an additional indication. Prolia can now be used as a treatment for increasing bone mass ...

THOUSAND OAKS, Calif., Nov. 5, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive data from the first three years of the open-label extension study of the pivotal Phase 3 fracture ...

Prolia® is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or ...

Xgeva and Prolia are two drugs Amgen investors need to keep an eye on. Thanks to label expansion that permitted wider use of the drugs, they've been Amgen's fastest-growing products this past year.

BEIJING, China and CAMBRIDGE, Mass., June 30, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing ...