The FDA has designated Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.
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 ...
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 ...
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, ...
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 ...
Findings showed denosumab-qbde demonstrated comparable quality, efficacy, safety, and immunogenicity to the reference product. Enoby is approved to treat postmenopausal women with osteoporosis at high ...
Biocon Biologics agreed to a settlement-and-license agreement with Amgen that will permit it to market drugs in the United States that are biosimilars to Amgen's Prolia and Xgeva. Both medications use ...
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 ...
The Food and Drug Administration has designated Celltrion’s Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) as interchangeable biosimilars to Prolia and Xgeva, respectively, for all approved ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback