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

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

On March 5, 2025, the FDA cleared an investigational new drug application for CTD402, a CD7-targeted universal CAR T-cell ...

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, ...

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

The FDA approved denosumab-bmwo for all indications of the reference drugs Prolia and Xgeva. According to a settlement between Amgen and Celltrion, the biosimilars can be launched as early as June 1.

Alvotech's 427% revenue surge in 2024—fueled by its biosimilar portfolio and global expansion—highlights the booming ...

Organon and Shanghai Henlius Biotech have announced that the European Medicines Agency (EMA) has validated a marketing authorisation application for HLX11, a biosimilar candidate referencing Roche’s ...

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

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Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence ® (denosumab-bnht) and Bomyntra ® (denosumab-bnht) of its operating company Fresenius ...