Drugs / MSB11022
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | — | — | “The application for marketing authorization for MSB11022 was submitted by Fresenius Kabi to the European Medicines Agency (EMA) at the end of last year.” fresenius.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 2 met primary | ||||||
| Phase 1 | NCT04018599 | Jul 2019 → Mar 2020 | Crohn disease, ankylosing spondylitis, hidradenitis suppurativa, polyarticular juvenile idiopathic arthritis +4 | Fresenius Kabi SwissBioSim GmbH | Completed | Met primary |
| Phase 1 | NCT03014947 | May → Dec 2014 | — | Fresenius Kabi SwissBioSim GmbH | Completed | Met primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT03052322 | Jan 2017 → May 2018 | rheumatoid arthritis | Fresenius Kabi SwissBioSim GmbH | Completed | No outcome recorded |
| Phase 3 | NCT02660580 | Feb → Dec 2016 | psoriasis | Fresenius Kabi SwissBioSim GmbH | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2019-02-01 | Fresenius Kabi | Regulatory Fresenius Kabi receives positive CHMP opinion for MSB11022, a biosimilar candidate of adalimumab fresenius.com ↗
Fresenius Kabi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending marketing authorization for MSB11022 a biosimilar candidate of Humira ® (adalimumab)*. |
| 2019-02-01 | Fresenius Kabi | Regulatory Fresenius Kabi receives positive CHMP opinion for MSB11022, a biosimilar candidate of adalimumab fresenius.com ↗
Fresenius Kabi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending marketing authorization for MSB11022 a biosimilar candidate of Humira® (adalimumab)*. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-02-01 | Fresenius Kabi | Fresenius Kabi receives positive CHMP opinion for MSB11022, a biosimilar candidate of adalimumab fresenius.com ↗ |
| 2019-02-01 | Fresenius Kabi | Fresenius Kabi receives positive CHMP opinion for MSB11022, a biosimilar candidate of adalimumab fresenius.com ↗ |
| 2018-10-18 | Fresenius Kabi | Fresenius Kabi reaches a global agreement with AbbVie regarding Fresenius Kabi’s adalimumab, MSB11022, a biosimilar candidate of AbbVie’s Humira® fresenius.com ↗ |
| 2018-10-18 | Fresenius Kabi | Fresenius Kabi reaches a global agreement with AbbVie regarding Fresenius Kabi’s adalimumab, MSB11022, a biosimilar candidate of AbbVie’s Humira® fresenius.com ↗ |
| 2016-03-02 | Merck KGaA, Darmstadt, Germany | Merck KGaA, Darmstadt, Germany Initiates Phase III Study of MSB11022, a Proposed Biosimilar of Adalimumab, in Chronic Plaque Psoriasis prnewswire.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MSB11022 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04018599 ↗ |
| Route | Subcutaneous | “Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and...” NCT02660580 ↗ |