- 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| Press Release
Related News:- The EC Grants Approval to Celltrion’s Omlyclo (Biosimilar, Xolair)
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