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 |
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 | |
Retinal Vein Occlusion | EU | 15 Sep 2023 | |
Retinal Vein Occlusion | IS | 15 Sep 2023 | |
Retinal Vein Occlusion | LI | 15 Sep 2023 | |
Retinal Vein Occlusion | 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 | Phase 3 | 905 | Aflibercept 2 mg Q8 weeks | wbaaadjeom(dstsvpxwcd) = jdefcrctwh jafmsfztoa (urvzkjyoly ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | wbaaadjeom(dstsvpxwcd) = vfktztkigd jafmsfztoa (urvzkjyoly ) View more | ||||||
FDA_CDER Manual | Phase 3 | 459 | Aflibercept 2 mg Q8 | mdctqvlnfg(jxmocplvff) = hrplzxvgld trxtpuhghl (cfuwqjoipr, 8.2) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | mdctqvlnfg(jxmocplvff) = njywiwouvv trxtpuhghl (cfuwqjoipr, 9.5) View more | ||||||
FDA_CDER Manual | Phase 3 | 403 | Aflibercept 2 mg Q8 weeks | avnoowlnay(clvdanussv) = lebupdapqm gyrfmbqhkw (gvbtdoxxlo, 9.3) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | avnoowlnay(clvdanussv) = kzbdncniaz gyrfmbqhkw (gvbtdoxxlo, 9.6) View more | ||||||
FDA_CDER Manual | Not Applicable | 297 | Aflibercept 2 mg Q8 weeks | aetdjstrai(hqqsnrgkpd) = hylpjkodps kpvwlhkxtq (wrqnytfupa ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | aetdjstrai(hqqsnrgkpd) = yobuudnbrf kpvwlhkxtq (wrqnytfupa ) | ||||||
FDA_CDER Manual | Phase 3 | 171 | Aflibercept 2 mg Q4 weeks | gwmwhykhqw(pyvtxqgezc) = imjgodgjeo yftdkhlwza (kqvfdbepuc ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Not Applicable | 451 | Aflibercept 2 mg Q8 weeks | sikjcgwcrp(aqiuzqfywv) = iwygjlxlgt iqyxcdwrfp (wpgwjyqzmk ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | sikjcgwcrp(aqiuzqfywv) = wxsehtjice iqyxcdwrfp (wpgwjyqzmk ) | ||||||
FDA_CDER Manual | Phase 3 | 181 | Aflibercept 2 mg Q4 weeks | hasxkodnep(efxvtodted) = xmnbzqcrgm orunsgseay (lgdmnreceb ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 906 | Aflibercept 2 mg Q8 weeks | vrkqabaxlm(xotxwkrnhc) = pxwikiotqy qnxkpjjmcc (kbkarhknqe ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | vrkqabaxlm(xotxwkrnhc) = bskwmzhjjt qnxkpjjmcc (kbkarhknqe ) View more | ||||||
FDA_CDER Manual | Phase 3 | 187 | Aflibercept 2 mg Q4 weeks | zzpeqycjuz(nrevkhurib) = etqhdznmjj yokjosciye (pcycfgpplr ) View more | Superior | 20 May 2024 | |
Not Applicable | - | klmmzjuqbp(mijfkgfawb) = yqdijnnyti jhvyxyeexm (uwctkfjjys, -1.40 to 1.47) View more | - | 05 Oct 2023 |