JD Supra5d
FDA Approves Fresenius’s Denosumab Biosimilars
On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), ...
Healio6d
FDA grants approval to two more denosumab biosimilars
The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, ...
Medscape6d
FDA Approves Fourth Denosumab Biosimilar
Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...
Managed Healthcare Executive6d
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...
Managed Healthcare Executive6d
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi ...
Center for Biosimilars6d
FDA Approves Another Pair of Denosumab Biosimilars, Conexxence and Bomyntra
The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for ...
PipelineReview.com6d
Fresenius Receives FDA Approval for their Denosumab Biosimilars and Secures Global Settlement Agreement
LAKE ZURICH, IL, USA I March 27, 2025 I Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® ...