Drugs / MSB11456
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | — | 2022-08-18 | “The European Medicines Agency (EMA) has accepted for review Fresenius Kabi’s Marketing Authorization Application (MAA) for MSB11456” fresenius.com ↗ |
| Filed | US (FDA) | — | — | 2022-08-01 | “The U.S. Food and Drug Administration (FDA) has accepted for review Fresenius Kabi's Biologics License Application (BLA) for MSB11456” fresenius.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03282851 | Nov 2017 → Oct 2019 | — | Fresenius Kabi SwissBioSim GmbH | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04512001 | Aug 2020 → Aug 2021 | rheumatoid arthritis | Fresenius Kabi SwissBioSim GmbH | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2023-07-21 | Fresenius Kabi | Regulatory Fresenius Kabi’s tocilizumab biosimilar receives positive opinion on Marketing Authorization Application (MAA) for Europe fresenius.com ↗
Fresenius Kabi’s tocilizumab biosimilar candidate, MSB11456, has received a positive recommendation for a marketing authorization from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). |
| 2023-07-21 | Fresenius Kabi | Regulatory Fresenius Kabi’s Tocilizumab Biosimilar Candidate MSB11456 Receives Positive CHMP Opinion
Fresenius Kabi’s tocilizumab biosimilar candidate MSB11456 receives positive CHMP opinion. fresenius-kabi.com ↗
Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today that the EMA CHMP has adopted a positive opinion recommending the granting of a marketing authorization for its tocilizumab biosimilar candidate MSB11456 referencing RoActemra®* (tocilizumab). |
| 2022-08-18 | Fresenius Kabi | Regulatory Fresenius Kabi’s regulatory submission for tocilizumab biosimilar accepted for review by EMA fresenius.com ↗
The European Medicines Agency (EMA) has accepted for review Fresenius Kabi’s Marketing Authorization Application (MAA) for MSB11456, a biosimilar candidate of RoActemra®*(tocilizumab). |
| 2022-08-01 | Fresenius Kabi | Regulatory Fresenius Kabi’s regulatory submission for tocilizumab biosimilar accepted for review by FDA fresenius.com ↗
The U.S. Food and Drug Administration (FDA) has accepted for review Fresenius Kabi's Biologics License Application (BLA) for MSB11456, a biosimilar candidate of Actemra®*(tocilizumab). |
| 2021-09-07 | Fresenius Kabi | Results Biosimilar candidate of Fresenius Kabi shows positive results in two clinical trials fresenius.com ↗
MSB11456, a tocilizumab biosimilar candidate, successfully met the primary and secondary endpoints in two consecutively conducted clinical trials. |
All press releases naming this drug 5 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MSB11456 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04512001 ↗ |
| Route | Other | “Subjects will receive a single injection of MSB11456 on Day 1.” NCT03282851 ↗ |