Drugs / GP2411
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | osteoporosis | 2023-05-25 | “today announced that the European Medicines Agency (EMA) has accepted the marketing authorization applications (MAA) for proposed biosimilar denosumab for regulatory review.” sandoz.com ↗ |
| Filed | US (FDA) | — | osteoporosis | 2023-02-06 | “today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab.” sandoz.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03974100 | Jul 2019 → Apr 2022 | postmenopausal osteoporosis | Sandoz | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-03-05 | Sandoz | Regulatory Sandoz receives FDA approval for first and only denosumab biosimilars sandoz.com ↗
Basel, March 5, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. |
| 2022-09-19 | Sandoz | Results Sandoz announces further progress on its biosimilar pipeline, with release of positive results for denosumab integrated Phase I/III clinical trial sandoz.com ↗
ROSALIA study met primary endpoints, confirming proposed biosimilar denosumab matches reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis |
| 2022-09-19 | Novartis Pharmaceuticals | Results Sandoz announces further progress on its biosimilar pipeline, with release of positive results for denosumab integrated Phase I/III clinical trial novartis.com ↗
ROSALIA study met primary endpoints, confirming proposed biosimilar denosumab matches reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis |
All press releases naming this drug 10 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GP2411 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03974100 ↗ |
| Known as | denosumab | “GP2411 (proposed biosimilar denosumab)” NCT03974100 ↗ |
| Route | Subcutaneous | “60 mg /mL subcutaneous injection every 6 months” NCT03974100 ↗ |