Fresenius Reports the US FDA’s BLA Acceptance of FKS518 (Biosimilar, Denosumab)

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Fresenius Reports the US FDA’s BLA Acceptance of FKS518 (Biosimilar, Denosumab)


  • The US FDA has accepted the BLA of the company’s FKS518, a biosimilar product of Prolia (denosumab) and Xgeva (denosumab)
  • The BLA was supported by the analytical development & similarity evaluation data from two trials comparing FKS518’s pharmacokinetic profile in one while efficacy and safety in another study with the reference
  • FKS518 is indicated for treating postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, increasing bone mass in high-risk men & women, preventing skeletal-related events in cancer patients, adults and skeletally mature adolescents having giant cell bone tumors and hypercalcemia

Ref: Fresenius Kabi | Image: Fresenius Kabi

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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