Drugs / FKS518
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, high fracture risk, osteoporosis in men, skeletal-related events in cancer, giant cell tumor of bone, hypercalcemia | 2024-05-27 | “the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for FKS518” fresenius-kabi.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04934072 | Jun 2021 → Aug 2023 | postmenopausal osteoporosis | Fresenius Kabi SwissBioSim GmbH | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-05-27 | Fresenius Kabi | Regulatory Fresenius Announces U.S. FDA Acceptance for Review of Biologics License Application for Denosumab Biosimilar Candidate
U.S. Food and Drug Administration has accepted for Review of Biologics License Application for our Denosumab Biosimilar Candidate fresenius-kabi.com ↗
Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for FKS518, its biosimilar candidate of Prolia® (denosumab) and Xgeva® (denosumab). |
| 2023-07-12 | Fresenius Kabi | Results Fresenius Kabi’s denosumab biosimilar candidate shows positive clinical trial results fresenius.com ↗
Fresenius Kabi announced today that its biosimilar candidate FKS518, a denosumab biosimilar candidate for the US reference product Prolia®*, successfully met its primary and secondary objectives in a recently conducted clinical trial on pharmacokinetic similarity. |
| 2023-07-12 | Fresenius Kabi | Results Fresenius Kabi’s Denosumab Biosimilar Candidate FKS518 Shows Positive Clinical Trial Results
Fresenius Kabi’ denosumab biosimilar candidate FKS518 shows positive clinical trial results. fresenius-kabi.com ↗
The study met all primary and secondary objectives and successfully demonstrated pharmacokinetic equivalence of FKS518 to the US reference product Prolia®. |
All press releases naming this drug 3 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FKS518 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04934072 ↗ |
| Route | Subcutaneous | “subcutaneously by single-use prefilled syringe (PFS)” NCT04934072 ↗ |