The FDA has designated Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.
The FDA has designated Conexxence and Bomyntra as interchangeable biosimilars to the reference products Prolia and Xgeva, ...
The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and XGEVA® (denosumab): Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo ...
The new approvals bring the number of denosumab biosimilars in the US to eight, but price reductions are not yet substantial.
Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today that the U.S. Food and Drug Administration (FDA ...
South Korea-based Celltrion today announced that the US Food and Drug Administration (FDA) has designated Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) as interchangeable biosimilars to the ...
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, ...
Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today that the U.S. Food and Drug Administration (FDA ...