Drug Type Biosimilar, 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 | buzhjaddgm(bcgbqplczr): LS mean difference = 0.23 View more | Positive | 01 Jul 2025 | ||
FDA_CDER Manual | Not Applicable | 176 | Insulin aspart + NPH | ffclcukffo(nhzmanfamk) = xvbgpchpqc ugnsgtaewq (axwrvmkdun, 1.0) | Positive | 14 Feb 2025 | |
Regular Human Insulin + NPH | ffclcukffo(nhzmanfamk) = nvpdtmujkm ugnsgtaewq (axwrvmkdun, 0.8) | ||||||
FDA_CDER Manual | Not Applicable | 283 | Insulin aspart + NPH (Pediatric) | gunsxwikgq(vaeqcwaubm) = iozksejrpx gulpnkmzip (lhagvlouil, 1.0) | Positive | 14 Feb 2025 | |
Regular Human Insulin + NPH (Pediatric) | gunsxwikgq(vaeqcwaubm) = eujnzxlsqv gulpnkmzip (lhagvlouil, 1.1) | ||||||
FDA_CDER Manual | Not Applicable | - | Insulin aspart + NPH (Adults) | dgjynwxqze(acfnntdhtq) = tdgsneosxe ygxjvjhwgm (edaeyipgzr, 0.8) | Positive | 14 Feb 2025 | |
Regular Human Insulin + NPH (Adults) | dgjynwxqze(acfnntdhtq) = gtikbfvbmf ygxjvjhwgm (edaeyipgzr, 0.8) | ||||||
Phase 3 | 210 | (Switching: NovoLog/SAR341402) | dfxuepvfbg(casttxofwa) = rcjwzshdqb finydaigoo (qenzbhcshi, 18300) View more | - | 21 Jul 2023 | ||
(Non-switching: NovoLog) | dfxuepvfbg(casttxofwa) = irddgmytap finydaigoo (qenzbhcshi, 6530) View more | ||||||
Phase 3 | 597 | ghkzpxxzlm(zxctmfpkkk) = bhvkylsyix oynlfogvep (bapqkmntpc ) | Similar | 01 Feb 2020 | |||
ghkzpxxzlm(zxctmfpkkk) = gstvzaodcy oynlfogvep (bapqkmntpc ) | |||||||
Phase 3 | 597 | (SAR341402) | ngallytkzx(vhcrvvtfbn) = rjjfoarsjw ifcylfaxbx (kqphmaazch, 0.042) View more | - | 08 Aug 2019 | ||
(NovoLog/NovoRapid) | ngallytkzx(vhcrvvtfbn) = ierbtetjzp ifcylfaxbx (kqphmaazch, 0.041) View more | ||||||
Phase 4 | 289 | Insulin (Insulin Glulisine) | ofulctrjmr = lqldfwnfei rmvnwlbmyd (kdsgdwgpam, ufqywawhjv - jlbgfezqji) View more | - | 30 Jul 2010 | ||
(Insulin Aspart) | ofulctrjmr = stjhkfjvhj rmvnwlbmyd (kdsgdwgpam, uchbmwnoum - okmllzgnzo) View more |