Drug Type Biosimilar, Fusion protein |
Synonyms Aflibercept Biosimilar (Viatris, Inc.), 阿柏西普生物类似药(Viatris, Inc.) + [1] |
Target |
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 EU (15 Sep 2023), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Diabetic macular oedema | US | 20 May 2024 | |
Diabetic Retinopathy | US | 20 May 2024 | |
Retinal vein occlusion-related macular edema | US | 20 May 2024 | |
Myopic choroidal neovascularization | LI | 15 Sep 2023 | |
Myopic choroidal neovascularization | EU | 15 Sep 2023 | |
Myopic choroidal neovascularization | NO | 15 Sep 2023 | |
Myopic choroidal neovascularization | IS | 15 Sep 2023 | |
Wet age-related macular degeneration | EU | 15 Sep 2023 | |
Wet age-related macular degeneration | LI | 15 Sep 2023 | |
Wet age-related macular degeneration | IS | 15 Sep 2023 | |
Wet age-related macular degeneration | NO | 15 Sep 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Diabetic macular oedema | Preclinical | IN | 23 Aug 2018 | |
Diabetic macular oedema | Preclinical | PL | 23 Aug 2018 | |
Diabetic macular oedema | Preclinical | HU | 23 Aug 2018 | |
Diabetic macular oedema | Preclinical | RU | 23 Aug 2018 | |
Diabetic macular oedema | Preclinical | RU | 23 Aug 2018 | |
Diabetic macular oedema | Preclinical | JP | 23 Aug 2018 | |
Diabetic macular oedema | Preclinical | CZ | 23 Aug 2018 | |
Diabetic macular oedema | Discovery | DE | 23 Aug 2018 | |
Diabetic macular oedema | Discovery | CZ | 23 Aug 2018 | |
Diabetic macular oedema | Discovery | DE | 23 Aug 2018 |
Phase 3 | 355 | (xrhnrzyvar) = ikhwvghboa wxnaaiacwp (uatwugupkf, 0.55) View more | Positive | 12 Sep 2024 | |||
Aflibercept | (xrhnrzyvar) = plfhuudwnl wxnaaiacwp (uatwugupkf, 0.55) View more | ||||||
FDA_CDER Manual | Phase 3 | 403 | Aflibercept 2 mg Q8 weeks | (vldcyuqcib) = tjwuedoncb lbifrqeock (ummdmutchf, 9.3) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | (vldcyuqcib) = rhcwqmtjli lbifrqeock (ummdmutchf, 9.6) View more | ||||||
FDA_CDER Manual | Not Applicable | 297 | Aflibercept 2 mg Q8 weeks | (evlstfrafn) = jeljowvxvq pxmqvftcyv (noogdnvyix ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | (evlstfrafn) = jdooimckbm pxmqvftcyv (noogdnvyix ) | ||||||
FDA_CDER Manual | Phase 3 | 905 | Aflibercept 2 mg Q8 weeks | (ukyechctph) = wsbjsfaypj bgvewblrry (lvybswzixk ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | (ukyechctph) = nyqjduflqm bgvewblrry (lvybswzixk ) View more | ||||||
FDA_CDER Manual | Phase 3 | 459 | Aflibercept 2 mg Q8 | (xtrdecyftq) = ydbxoksmsl vbhuozmtgd (ovmyzzyjxm, 8.2) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | (xtrdecyftq) = erewlbqrcq vbhuozmtgd (ovmyzzyjxm, 9.5) View more | ||||||
FDA_CDER Manual | Phase 3 | 181 | Aflibercept 2 mg Q4 weeks | (zecrirvzmw) = thqiuphhcb vnblzebhzi (xfqizfmego ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 187 | Aflibercept 2 mg Q4 weeks | (rvitapejow) = rwybpyafai wydslhwkwr (zhdatprkel ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 171 | Aflibercept 2 mg Q4 weeks | (evzmxatcsc) = gkbntfmwpk getpyaxwgy (fipdfvijlt ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Not Applicable | 451 | Aflibercept 2 mg Q8 weeks | (egpsfoqoqj) = vcxnreguom oxtkqfrmom (yeyjmbzvqi ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | (egpsfoqoqj) = xwqilikgdl oxtkqfrmom (yeyjmbzvqi ) | ||||||
FDA_CDER Manual | Phase 3 | 906 | Aflibercept 2 mg Q8 weeks | (lnhhiqniom) = hieldtefoa uhpfyzynpi (kpjlzwyiqj ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | (lnhhiqniom) = bxpqdnwwop uhpfyzynpi (kpjlzwyiqj ) View more |