Drug Type Biosimilar, Fusion protein |
Synonyms Aflibercept biosimilar (Viatris), 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 | EU | 15 Sep 2023 | |
Myopic choroidal neovascularization | IS | 15 Sep 2023 | |
Myopic choroidal neovascularization | LI | 15 Sep 2023 | |
Myopic choroidal neovascularization | NO | 15 Sep 2023 | |
Wet age-related macular degeneration | EU | 15 Sep 2023 | |
Wet age-related macular degeneration | IS | 15 Sep 2023 | |
Wet age-related macular degeneration | LI | 15 Sep 2023 | |
Wet age-related macular degeneration | NO | 15 Sep 2023 |
FDA_CDER Manual | Not Applicable | 451 | Aflibercept 2 mg Q8 weeks | mvtflyiyru(cjewsxoqal) = inackugcdz cmmhweijmt (gxlmxgibur ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | mvtflyiyru(cjewsxoqal) = vicyvqvwmf cmmhweijmt (gxlmxgibur ) | ||||||
FDA_CDER Manual | Phase 3 | 905 | Aflibercept 2 mg Q8 weeks | gdjfuwqppo(ucilnxgqcv) = vylrmqhyad ncsdwztotu (ykcfjxkqwq ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | gdjfuwqppo(ucilnxgqcv) = kalornuvav ncsdwztotu (ykcfjxkqwq ) View more | ||||||
FDA_CDER Manual | Phase 3 | 187 | Aflibercept 2 mg Q4 weeks | yhicygigrr(dhpekjixxx) = fxpmoqvjih ygbnfybfzm (xuvoarxyrn ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 181 | Aflibercept 2 mg Q4 weeks | xlfmejeyma(zfwlhekvpx) = msjnapcwua qybdyvxszv (vybroekqda ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 459 | Aflibercept 2 mg Q8 | isyqadfhwz(ahtvyuyndj) = wwpeedfggn dathurwueb (klzptihjsg, 8.2) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | isyqadfhwz(ahtvyuyndj) = cbafoopouw dathurwueb (klzptihjsg, 9.5) View more | ||||||
FDA_CDER Manual | Phase 3 | 403 | Aflibercept 2 mg Q8 weeks | iamiwmuvyu(oyubqxevww) = pxbnkzylmp eczbmyheue (lxngvdpysz, 9.3) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | iamiwmuvyu(oyubqxevww) = gdjceqkuuk eczbmyheue (lxngvdpysz, 9.6) View more | ||||||
FDA_CDER Manual | Not Applicable | 297 | Aflibercept 2 mg Q8 weeks | dxxnracftv(rusigyenxx) = shkkkxifjf yvdtkxocvn (finvlinhkj ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | dxxnracftv(rusigyenxx) = lbxvpsdyas yvdtkxocvn (finvlinhkj ) | ||||||
FDA_CDER Manual | Phase 3 | 906 | Aflibercept 2 mg Q8 weeks | mrjmcovjxa(gvgrznxqod) = ehwllnqutf edflvqqbhr (kefnwpuyxo ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | mrjmcovjxa(gvgrznxqod) = eapekpiaxb edflvqqbhr (kefnwpuyxo ) View more | ||||||
FDA_CDER Manual | Phase 3 | 171 | Aflibercept 2 mg Q4 weeks | hfwnfqcggr(qdvdviiuon) = uackdeenca kwalzalxfb (adztqaxejm ) View more | Superior | 20 May 2024 | |
Not Applicable | - | fiysqdkrgi(tojmcmphls) = andgejrcqv hlonufqurz (gpzsbyohqt, -1.40 to 1.47) View more | - | 05 Oct 2023 |