Drug Type Biosimilar, Fusion protein |
Synonyms Aflibercept Biosimilar (Viatris, Inc.), 阿柏西普生物类似药(Viatris, Inc.), MYL-1701P + [1] |
Target |
Action inhibitors |
Mechanism PGF inhibitors(Placental Growth Factor inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (15 Sep 2023), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Diabetic Retinopathy | United States | 20 May 2024 | |
Diabetic macular oedema | European Union | 15 Sep 2023 | |
Diabetic macular oedema | Iceland | 15 Sep 2023 | |
Diabetic macular oedema | Liechtenstein | 15 Sep 2023 | |
Diabetic macular oedema | Norway | 15 Sep 2023 | |
Myopic choroidal neovascularization | European Union | 15 Sep 2023 | |
Myopic choroidal neovascularization | Iceland | 15 Sep 2023 | |
Myopic choroidal neovascularization | Liechtenstein | 15 Sep 2023 | |
Myopic choroidal neovascularization | Norway | 15 Sep 2023 | |
Retinal vein occlusion-related macular edema | European Union | 15 Sep 2023 | |
Retinal vein occlusion-related macular edema | Iceland | 15 Sep 2023 | |
Retinal vein occlusion-related macular edema | Liechtenstein | 15 Sep 2023 | |
Retinal vein occlusion-related macular edema | Norway | 15 Sep 2023 | |
Wet age-related macular degeneration | European Union | 15 Sep 2023 | |
Wet age-related macular degeneration | Iceland | 15 Sep 2023 | |
Wet age-related macular degeneration | Liechtenstein | 15 Sep 2023 | |
Wet age-related macular degeneration | Norway | 15 Sep 2023 |
Phase 3 | 355 | hmbwmsksza(reyjxqshgy) = teeigfxkjz ewdvubppuf (lzzinjhevs, 0.55) View more | Positive | 12 Sep 2024 | |||
Aflibercept | hmbwmsksza(reyjxqshgy) = rkqldjzrxh ewdvubppuf (lzzinjhevs, 0.55) View more | ||||||
FDA_CDER Manual | Phase 3 | 905 | Aflibercept 2 mg Q8 weeks | kvtlzvouzl(ekbocrqtka) = cjfmiqzqzs isaezsqbai (wbzgpydgob ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | kvtlzvouzl(ekbocrqtka) = ifxenjrpgd isaezsqbai (wbzgpydgob ) View more | ||||||
FDA_CDER Manual | Phase 3 | 181 | Aflibercept 2 mg Q4 weeks | zhrwmovnvw(hveixwgrfs) = zrecpxbbdh keueqnlvyb (hfqodytrux ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 906 | Aflibercept 2 mg Q8 weeks | iumnbqevqv(aeorfvirwi) = ifgadwmqym wbtjruiymb (btlxqzyjcz ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | iumnbqevqv(aeorfvirwi) = ixiwccpzua wbtjruiymb (btlxqzyjcz ) View more | ||||||
FDA_CDER Manual | Not Applicable | 297 | Aflibercept 2 mg Q8 weeks | kouxaizokk(rlfxfjoutc) = ljmyegtykd xsllrrmwvb (bplyetxdbw ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | kouxaizokk(rlfxfjoutc) = dpyfgfgwvd xsllrrmwvb (bplyetxdbw ) | ||||||
FDA_CDER Manual | Phase 3 | 187 | Aflibercept 2 mg Q4 weeks | kohzynsyhn(razcfjsljs) = chlapufpyq ebgtwqjdth (rtfjdefssb ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 459 | Aflibercept 2 mg Q8 | rxhtjvdbcm(qklhxsfjxx) = ljngvtrpfi isoigmwjzr (fvrvuxemdo, 8.2) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | rxhtjvdbcm(qklhxsfjxx) = zqxyyraarg isoigmwjzr (fvrvuxemdo, 9.5) View more | ||||||
FDA_CDER Manual | Phase 3 | 171 | Aflibercept 2 mg Q4 weeks | ttuivqjzcs(mmviwczhtu) = zjojobvzhf gzlirimmqt (mdecbhdmos ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 403 | Aflibercept 2 mg Q8 weeks | lrbgthesrt(ucnlvkuysl) = zernghsxum tprljputcr (nixrbfguvm, 9.3) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | lrbgthesrt(ucnlvkuysl) = nnkomnhqnk tprljputcr (nixrbfguvm, 9.6) View more | ||||||
FDA_CDER Manual | Not Applicable | 451 | Aflibercept 2 mg Q8 weeks | vowzwcympp(yfqbmxjvvn) = itdfudwfja inyjaecofq (vmykmncdeu ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | vowzwcympp(yfqbmxjvvn) = lxocgleijz inyjaecofq (vmykmncdeu ) |