The Food and Drug Administration (FDA) has designated Conexxence ® (denosumab-bnht) and Bomyntra ® (denosumab-bnht) as interchangeable biosimilars to the reference products Prolia ® (denosumab) and ...
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.
The new approvals bring the number of denosumab biosimilars in the US to eight, but price reductions are not yet substantial.
US FDA grants interchangeability designation to Celltrion's denosumab biosimilars, Stoboclo and Osenvelt: Incheon, South Korea Friday, October 31, 2025, 10:00 Hrs [IST] Celltrion, ...
Amgen is celebrating the news that regulators in the USA have given a second green light to the biotech's key compound denosumab. Amgen is celebrating the news that regulators in the USA have given a ...
BENGALURU, India and BRIDGEWATER, N.J., Sept. 17, 2025 /PRNewswire/ -- Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of ...
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