Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for ...

The FDA has approved two new denosumab biosimilars that are interchangeable with the reference medications Prolia and Xgeva, ...

Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...

The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for ...

The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, ...

Number 5: Biosimilar natalizumab demonstrated comparable efficacy, safety, and immunogenicity to reference drug Tysabri in ...

On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), ...

The study explores whether Prolia/Xgeva (denosumab), a widely used therapy for osteoporosis and bone tumors, can regenerate ...

LAKE ZURICH, IL, USA I March 27, 2025 I Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® ...

The Food and Drug Administration has approved Fresenius Kabi's Biologics License Application for the denosumab biosimilars Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). These ...

“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 ...