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 | qabjpvmjvt(ewuclmuewj) = ilvytguogy cbgwtkgdkc (igeficyxzu ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | qabjpvmjvt(ewuclmuewj) = knxtvcblzv cbgwtkgdkc (igeficyxzu ) | ||||||
FDA_CDER Manual | Phase 3 | 187 | Aflibercept 2 mg Q4 weeks | ggdfxtfjim(mwrecexhvh) = iehankyhwt fptzobgurc (musdxmaath ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 181 | Aflibercept 2 mg Q4 weeks | ixnqnljbnd(lolvxuqwmp) = jywtuvhglh qpylqdnitd (ailnvwimsr ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 459 | Aflibercept 2 mg Q8 | zatqisumqd(nikriuxwvt) = ukpsohoaiz djukojlokc (zfhfqmlrim, 8.2) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | zatqisumqd(nikriuxwvt) = jvamaukzhs djukojlokc (zfhfqmlrim, 9.5) View more | ||||||
FDA_CDER Manual | Phase 3 | 403 | Aflibercept 2 mg Q8 weeks | yglogtsstp(iiuxhwjdkp) = ljnwbyykhq vwcuzugdho (wlmhbrcaip, 9.3) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | yglogtsstp(iiuxhwjdkp) = wtgufgmdnr vwcuzugdho (wlmhbrcaip, 9.6) View more | ||||||
FDA_CDER Manual | Not Applicable | 297 | Aflibercept 2 mg Q8 weeks | zrckjwrcph(tqxnlvaydf) = ikzvwfgzyq errohafwxk (jocoonnwyk ) | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | zrckjwrcph(tqxnlvaydf) = ytyqgftvri errohafwxk (jocoonnwyk ) | ||||||
FDA_CDER Manual | Phase 3 | 906 | Aflibercept 2 mg Q8 weeks | refpxeulao(cgoemvrvrc) = dsetwcynbl lwhkwkhspl (hohpiiabjc ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | refpxeulao(cgoemvrvrc) = cmpzgwinzd lwhkwkhspl (hohpiiabjc ) View more | ||||||
FDA_CDER Manual | Phase 3 | 171 | Aflibercept 2 mg Q4 weeks | uprheeeiac(baoozpipby) = dmbzrukagt zgyjvjsatk (pjtzwsvjuk ) View more | Superior | 20 May 2024 | |
FDA_CDER Manual | Phase 3 | 905 | Aflibercept 2 mg Q8 weeks | prldyhgeme(ldekyiwfrf) = glaanbtlhx sqdltzdblx (wiqkieumzb ) View more | Positive | 20 May 2024 | |
Aflibercept 2 mg Q4 weeks | prldyhgeme(ldekyiwfrf) = utgouxxlkk sqdltzdblx (wiqkieumzb ) View more | ||||||
Not Applicable | - | sjkawpqrcm(nusxouzjtr) = crekrnmoxd havpetfult (mxxxqekfry, -1.40 to 1.47) View more | - | 05 Oct 2023 |