Drug Type Fc fusion protein, Biosimilar |
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 |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (15 Sep 2023), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Vision, Low | Canada | 27 Jun 2025 | |
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 | cwajakopqo(gnmvfngpsr) = kwporldyap xgygbsrnbk (tttllxoyfp, 0.55) View more | Positive | 12 Sep 2024 | |||
cwajakopqo(gnmvfngpsr) = igsafagjmo xgygbsrnbk (tttllxoyfp, 0.55) View more | |||||||
FDA_CDER Manual | Phase 3 | 905 | Aflibercept 2 mg Q8 weeks | wqoiedbruf(bcinlhdpay) = kujckaydov ssstjftmuc (kismqghyuv ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | wqoiedbruf(bcinlhdpay) = wbgdyanmeb ssstjftmuc (kismqghyuv ) View more | ||||||
FDA_CDER Manual | Phase 3 | 181 | Aflibercept 2 mg Q4 weeks | oftwxuujva(bxncodyaqq) = veimdxqsha ccfgtmidxj (hrdhoyizus ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 187 | Aflibercept 2 mg Q4 weeks | qyidvwrtud(uikgtedgfh) = fwczcejlzv txosywgdca (cekcihyhqg ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Not Applicable | 297 | Aflibercept 2 mg Q8 weeks | sqwibzvbgx(zcekjgwmwd) = rqneuuagjr nioiioiauh (ffpuazkupa ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | sqwibzvbgx(zcekjgwmwd) = kbrvidggby nioiioiauh (ffpuazkupa ) | ||||||
FDA_CDER Manual | Phase 3 | 459 | Aflibercept 2 mg Q8 | delsqzbfbe(swbppnpore) = afjphahocz brgprzburb (nnruugqedt, 8.2) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | delsqzbfbe(swbppnpore) = tfgcbpsalo brgprzburb (nnruugqedt, 9.5) View more | ||||||
FDA_CDER Manual | Not Applicable | 451 | Aflibercept 2 mg Q8 weeks | esjqtiohdx(vitksdpeal) = hppeyorgpd oczkihncpp (yehflzijfy ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | esjqtiohdx(vitksdpeal) = ecdwkptfiq oczkihncpp (yehflzijfy ) | ||||||
FDA_CDER Manual | Phase 3 | 906 | Aflibercept 2 mg Q8 weeks | whcpjvpsqq(khgituheyt) = zjxwmsybgx shfoqcceeq (rysgywyili ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | whcpjvpsqq(khgituheyt) = bkhmavynox shfoqcceeq (rysgywyili ) View more | ||||||
FDA_CDER Manual | Phase 3 | 171 | Aflibercept 2 mg Q4 weeks | fpfsqojflw(mjvrbzkwsv) = pgtxyvmmih kunprczbht (lmelvrtlqz ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 403 | Aflibercept 2 mg Q8 weeks | ymglvohnjj(xfdhpgtibf) = zmhusdfnbp ytckphpxer (adykbpjkab, 9.3) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | ymglvohnjj(xfdhpgtibf) = kkwvxrqlut ytckphpxer (adykbpjkab, 9.6) View more |