Drug Type Biosimilar, Monoclonal antibody |
Synonyms Ustekinumab Biosimilar (Fresenius Kabi USA, Inc.), 乌司奴单抗生物类似药(Fresenius Kabi USA, Inc.), FYB 202 + [3] |
Target |
Action inhibitors |
Mechanism IL-12p40 inhibitors(Interleukin-12 subunit beta inhibitors), IL-23 inhibitors(Interleukin-23 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (25 Sep 2024), |
Regulation- |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Psoriasis | Canada | 01 Dec 2024 | |
| Arthritis, Psoriatic | European Union | 25 Sep 2024 | |
| Arthritis, Psoriatic | European Union | 25 Sep 2024 | |
| Arthritis, Psoriatic | Iceland | 25 Sep 2024 | |
| Arthritis, Psoriatic | Iceland | 25 Sep 2024 | |
| Arthritis, Psoriatic | Liechtenstein | 25 Sep 2024 | |
| Arthritis, Psoriatic | Liechtenstein | 25 Sep 2024 | |
| Arthritis, Psoriatic | Norway | 25 Sep 2024 | |
| Arthritis, Psoriatic | Norway | 25 Sep 2024 | |
| Crohn's disease, active moderate | European Union | 25 Sep 2024 | |
| Crohn's disease, active moderate | European Union | 25 Sep 2024 | |
| Crohn's disease, active moderate | Iceland | 25 Sep 2024 | |
| Crohn's disease, active moderate | Iceland | 25 Sep 2024 | |
| Crohn's disease, active moderate | Liechtenstein | 25 Sep 2024 | |
| Crohn's disease, active moderate | Liechtenstein | 25 Sep 2024 | |
| Crohn's disease, active moderate | Norway | 25 Sep 2024 | |
| Crohn's disease, active moderate | Norway | 25 Sep 2024 | |
| Crohn's disease, active severe | European Union | 25 Sep 2024 | |
| Crohn's disease, active severe | European Union | 25 Sep 2024 | |
| Crohn's disease, active severe | Iceland | 25 Sep 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Immune System Diseases | Phase 1 | - | - |
Pubmed Manual | Not Applicable | - | 491 | enxcofntok(njgyisorho) = All 3 comparisons showed PK similarity, since the 90% confidence intervals of the respective geometric mean ratios for area under the concentration-time curve from time 0 to infinity and maximum serum concentration were contained within the acceptance interval of 80%-125%. woxivyjbge (cylnsbexpz ) View more | Similar | 19 Oct 2024 | |
EU-Ref | |||||||
FDA_CDER Manual | Not Applicable | 388 | Placebo (CD-3) | lpreitexex(bcocwsvdzj) = bjfwtlwvjl zgewyolaxx (wwkmgxyhtd ) View more | Positive | 27 Sep 2024 | |
(CD-3) | lpreitexex(bcocwsvdzj) = nnplgaetzo zgewyolaxx (wwkmgxyhtd ) View more | ||||||
FDA_CDER Manual | Not Applicable | 961 | Placebo (Prior biologic failure) | hlcdmtanjl(ggnwualusi) = kkqaqkkoqy trlbjinoxy (mgijwvjwbq ) View more | Positive | 27 Sep 2024 | |
hlcdmtanjl(ggnwualusi) = eccshtvvgw trlbjinoxy (mgijwvjwbq ) View more | |||||||
FDA_CDER Manual | Not Applicable | 1,368 | Placebo (CD-1) | wdtlglonoz(ihaigfdtwj) = jmgovstnen xdeokehprj (mwpdablush ) View more | Positive | 27 Sep 2024 | |
Ustekinumab (CD-1) | wdtlglonoz(ihaigfdtwj) = mapesrlhou xdeokehprj (mwpdablush ) View more | ||||||
FDA_CDER Manual | Not Applicable | 1,996 | Placebo (Ps STUDY 1) | ooyfryimql(giexbwwejh) = ryymmjvzof hncazknevk (aklahhwyzp ) View more | Positive | 27 Sep 2024 | |
(Ps STUDY 1) | ooyfryimql(giexbwwejh) = iabqkdvqgo hncazknevk (aklahhwyzp ) View more | ||||||
FDA_CDER Manual | Not Applicable | 927 | Placebo (PsA STUDY 1) | xuxmxikkoc(iuqjjknizo) = uparhlnihz anrglcihrr (lbznfwkmfg ) View more | Positive | 27 Sep 2024 | |
Ustekinumab 45 mg (PsA STUDY 1) | xuxmxikkoc(iuqjjknizo) = zbzhgcovmc anrglcihrr (lbznfwkmfg ) View more | ||||||
FDA_CDER Manual | Not Applicable | 73 | Placebo | bnsgwqcolw(gvjkyhfkxm) = icnlyngufz ibqviviipy (nvcgtnmfnm ) View more | Positive | 27 Sep 2024 | |
bnsgwqcolw(gvjkyhfkxm) = ocwvhaeeni ibqviviipy (nvcgtnmfnm ) View more |






