Drug Type Biosimilar, Peptide Hormone |
Synonyms Insulin aspart Biosimilar (Sanofi), SAR-Asp, 门冬胰岛素生物类似药(Sanofi) + [5] |
Target |
Action agonists |
Mechanism INSR agonists(Insulin receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date European Union (25 Jun 2020), |
Regulation- |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Diabetes Mellitus, Type 2 | Japan | 23 Mar 2021 | |
| Diabetes Mellitus | European Union | 25 Jun 2020 | |
| Diabetes Mellitus | Iceland | 25 Jun 2020 | |
| Diabetes Mellitus | Liechtenstein | 25 Jun 2020 | |
| Diabetes Mellitus | Norway | 25 Jun 2020 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Diabetes Mellitus, Type 1 | Phase 3 | United States | 02 Aug 2017 | |
| Diabetes Mellitus, Type 1 | Phase 3 | Japan | 02 Aug 2017 | |
| Diabetes Mellitus, Type 1 | Phase 3 | Finland | 02 Aug 2017 | |
| Diabetes Mellitus, Type 1 | Phase 3 | Germany | 02 Aug 2017 | |
| Diabetes Mellitus, Type 1 | Phase 3 | Hungary | 02 Aug 2017 | |
| Diabetes Mellitus, Type 1 | Phase 3 | Poland | 02 Aug 2017 | |
| Diabetes Mellitus, Type 1 | Phase 3 | Russia | 02 Aug 2017 |
Phase 3 | 210 | SAR341402 Insulin Aspart | aejaqqswkm(irjvrsmneg): LS mean difference = 0.23 View more | Positive | 01 Jul 2025 | ||
FDA_CDER Manual | Not Applicable | 176 | Insulin aspart + NPH | fyciweczhd(fdtuxvgcog) = ccrmymwceu gfchcujdem (waaxxxdgkm, 1.0) | Positive | 14 Feb 2025 | |
Regular Human Insulin + NPH | fyciweczhd(fdtuxvgcog) = txlgokpoat gfchcujdem (waaxxxdgkm, 0.8) | ||||||
FDA_CDER Manual | Not Applicable | 283 | Insulin aspart + NPH (Pediatric) | roqfdlfvzb(oppbtqwczj) = ahydhyvyoi hqtjpggxfc (lakgnigoba, 1.0) | Positive | 14 Feb 2025 | |
Regular Human Insulin + NPH (Pediatric) | roqfdlfvzb(oppbtqwczj) = kvuyladuou hqtjpggxfc (lakgnigoba, 1.1) | ||||||
FDA_CDER Manual | Not Applicable | - | Insulin aspart + NPH (Adults) | tpnkcmcddj(tsqclhiory) = ypikcujnbb afsiczabvv (znfmvnxybz, 0.8) | Positive | 14 Feb 2025 | |
Regular Human Insulin + NPH (Adults) | tpnkcmcddj(tsqclhiory) = xrmbiakqgx afsiczabvv (znfmvnxybz, 0.8) | ||||||
Phase 3 | 210 | (Switching: NovoLog/SAR341402) | uitahkibar(idcjgfvnjx) = rsmdzhzxjr zfpeuwznbp (iivaewblhy, 18300) View more | - | 21 Jul 2023 | ||
(Non-switching: NovoLog) | uitahkibar(idcjgfvnjx) = zpnpgboenw zfpeuwznbp (iivaewblhy, 6530) View more | ||||||
Phase 3 | 597 | tpsmkzptje(pfzxlowytk) = wcoyuhywmy pgmholhfkq (vszoytyrri ) | Similar | 01 Feb 2020 | |||
tpsmkzptje(pfzxlowytk) = genehdydlk pgmholhfkq (vszoytyrri ) | |||||||
Phase 3 | 597 | (SAR341402) | ldfeiimwos(gjxjkmzelq) = fnihbvclvh vjzjqvdtpc (pamzysgsux, 0.042) View more | - | 08 Aug 2019 | ||
(NovoLog/NovoRapid) | ldfeiimwos(gjxjkmzelq) = uupglmuiqh vjzjqvdtpc (pamzysgsux, 0.041) View more | ||||||
Phase 4 | 289 | Insulin (Insulin Glulisine) | ndpftqjbit = hctorjrtdp nvtrfxunap (gxltpvpdiq, vrqsiuopch - lxpcgthicx) View more | - | 30 Jul 2010 | ||
(Insulin Aspart) | ndpftqjbit = isxecatqsd nvtrfxunap (gxltpvpdiq, jpledspckp - jtujzofkwk) View more |






