Drugs / MSB11455
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2020-05-27 | “U.S. Food and Drug Administration (FDA) has accepted for review the company`s Biologics License Application (BLA) for MSB11455” fresenius.com ↗ |
| Filed | EU (EMA) | — | — | 2020-05-22 | “The European Medicines Agency (EMA) has accepted for review Fresenius Kabi`s Marketing Authorization Application (MAA) for MSB11455” fresenius.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03251248 | Aug 2017 → May 2018 | — | Fresenius Kabi SwissBioSim GmbH | Completed | Met primary |
| Phase 1 | NCT03251339 | Aug 2017 → Feb 2018 | — | Fresenius Kabi SwissBioSim GmbH | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2020-05-27 | Fresenius Kabi | Regulatory Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by FDA fresenius.com ↗
Fresenius Kabi announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company`s Biologics License Application (BLA) for MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)*. |
| 2020-05-22 | Fresenius Kabi | Regulatory Fresenius Kabi’s regulatory submission for pegfilgrastim 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 MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)*. |
| 2018-10-09 | Fresenius Kabi | Results Fresenius Kabi biosimilar candidate meets primary endpoints in the two pivotal clinical studies fresenius.com ↗
MSB11455, a biosimilar candidate for Neulasta ® (pegfilgrastim), has met its primary endpoints in the two pivotal clinical studies. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-05-27 | Fresenius Kabi | Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by FDA fresenius.com ↗ |
| 2020-05-22 | Fresenius Kabi | Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by EMA fresenius.com ↗ |
| 2018-10-09 | Fresenius Kabi | Fresenius Kabi biosimilar candidate meets primary endpoints in the two pivotal clinical studies fresenius.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MSB11455 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03251248 ↗ |
| Route | Subcutaneous | “Subjects received a single subcutaneous dose of MSB11455 or the reference product (both 6 mg/0.6 mL) on Day 1 of each study period.” PMID 32660769 ↗ Jul 2020 |