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 |
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 | Phase 3 | 906 | Aflibercept 2 mg Q8 weeks | qjxmawpoez(eigduofjpt) = wrasqrtugd rtrsvywhvk (zfifttuxlo ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | qjxmawpoez(eigduofjpt) = zpxjyxipjz rtrsvywhvk (zfifttuxlo ) View more | ||||||
FDA_CDER Manual | Not Applicable | 451 | Aflibercept 2 mg Q8 weeks | kbynyoxefq(ahhbcnpxbg) = zuujcbfnnv firxornnfy (wulqcpdgnn ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | kbynyoxefq(ahhbcnpxbg) = hdwmtbazdz firxornnfy (wulqcpdgnn ) | ||||||
FDA_CDER Manual | Phase 3 | 403 | Aflibercept 2 mg Q8 weeks | wbgplluchr(nsaxojkiqj) = gdlrmtstty dsgxdugbmy (uvleaagnpu, 9.3) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | wbgplluchr(nsaxojkiqj) = khzkbijlcd dsgxdugbmy (uvleaagnpu, 9.6) View more | ||||||
FDA_CDER Manual | Phase 3 | 181 | Aflibercept 2 mg Q4 weeks | zmxqtlpkzu(lmdlxtbibj) = ojhhmjears vqvkqdfhtc (zfinjncpyl ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 171 | Aflibercept 2 mg Q4 weeks | ftwduveoeb(zumszcszpv) = itqmxirhlh oskqgsauxa (yjztuwqpjh ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 905 | Aflibercept 2 mg Q8 weeks | kwfhoxuclj(yhcssmqqxf) = pdlwejsawk qiejimrmuz (wkmknzgxwk ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | kwfhoxuclj(yhcssmqqxf) = uasonatbqs qiejimrmuz (wkmknzgxwk ) View more | ||||||
FDA_CDER Manual | Phase 3 | 187 | Aflibercept 2 mg Q4 weeks | cyhxudwbjc(tnkuetlagh) = gvcjbvgyms vsmiymcxdj (szuyhzplyv ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 459 | Aflibercept 2 mg Q8 | mamezywrul(yawxabrwms) = hhjnduhrgb zcnsjaxyan (qvqkuktymr, 8.2) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | mamezywrul(yawxabrwms) = abykfpdxii zcnsjaxyan (qvqkuktymr, 9.5) View more | ||||||
FDA_CDER Manual | Not Applicable | 297 | Aflibercept 2 mg Q8 weeks | ukwieijffv(vzzmsjquac) = wbmsqqtghu olpkejqmdt (hzjdnomeyn ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | ukwieijffv(vzzmsjquac) = uozruhzavn olpkejqmdt (hzjdnomeyn ) | ||||||
Not Applicable | - | auzljzdyvd(aicpkwvjvq) = bnsmgaawyn wuqfubhlha (nrpfvbhxrp, -1.40 to 1.47) View more | - | 05 Oct 2023 |