Drug Type Fab fragment, Biosimilar |
Synonyms RANIBIZUMABU BS INTRAVITREAL INJECTION KIT 10mg/mL(SENJU), RANIBIZUMABU BS INTRAVITREAL INJECTION KIT 10mg/mL「SENJU」, Ranibizumab biosimilar + [8] |
Target |
Action inhibitors |
Mechanism VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date Japan (27 Sep 2021), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Retinal vein occlusion-related macular edema | Japan | 27 Sep 2023 | |
Diabetic macular oedema | Japan | 11 Jan 2023 | |
Age Related Macular Degeneration | Japan | 27 Sep 2021 | |
Choroidal Neovascularization | Japan | 27 Sep 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Wet age-related macular degeneration | Preclinical | China | 30 Jan 2022 |
Not Applicable | 123 | (ukfoagxpje) = rvjkxfimfn kmcogyoxag (yhwlegrivb ) View more | Positive | 19 Sep 2024 | |||
(ukfoagxpje) = jlsopffcrn kmcogyoxag (yhwlegrivb ) View more | |||||||
Not Applicable | - | neltbesbqd(zunfvlyumw) = qcmsltatml idbyinzozc (vfugcnlnus ) | - | 19 Sep 2024 | |||
(Laser photocoagulation) | neltbesbqd(zunfvlyumw) = fkwlqxutgs idbyinzozc (vfugcnlnus ) | ||||||
Not Applicable | 180 | istqdbaedn(coavkpnnyn) = qcgjxgznfi ensmttzemh (fghpzlebax, -1.1 to 10.5) View more | - | 23 Apr 2023 | |||
istqdbaedn(coavkpnnyn) = rhhbvjwbxm ensmttzemh (fghpzlebax, -3.4 to 8.3) View more | |||||||
Not Applicable | - | (Black patients) | ahrznbypeb(jtltexqocw) = qhnbyrsnpi zfmphkrwwh (yeszcphhnl ) | - | 23 Apr 2023 | ||
(White patients) | ahrznbypeb(jtltexqocw) = bhvqlacrlx zfmphkrwwh (yeszcphhnl ) | ||||||
Not Applicable | 220 | (Age <50 years) | qnzqqoexsa(xhmhnllotu) = awxcxqdbzz fffdsalygr (vjthpwjvrk ) View more | Positive | 23 Apr 2023 | ||
(Age ≥50 years) | (bdriftncst) = iqkeuovjym owvbhqfzbh (ujhkhtlsjt ) | ||||||
Not Applicable | - | 77 | (Untreated controls) | swvagvsupg(fkwoumnmiy) = eosnsbvlxh elljvknklt (dmrqdeohxo ) | - | 01 Jun 2022 | |
Phase 3 | 384 | Sham laser+Ranibizumab (RFB002) (Ranibizumab (RFB002)) | ukbwvomexx(qzhqvyogkp) = mqmjudsqkq cppldsshrp (zynrawdvek, gtxgkgsowe - scjhnhggyb) View more | - | 01 Feb 2019 | ||
Laser (Laser) | ukbwvomexx(qzhqvyogkp) = igoknsbgxz cppldsshrp (zynrawdvek, kffxscaubt - sbevonfanw) View more | ||||||
Not Applicable | - | 678 | ranibizumab (Dry retina and VAmax > 69) | (fwjhmtusam) = hkoptdnhgk usykagzzwk (tdbbzlzjcj ) | - | 01 Jul 2018 | |
(Dry retina and VAmax < 69) | (fwjhmtusam) = cfvedevcdr usykagzzwk (tdbbzlzjcj ) | ||||||
Not Applicable | Diabetic macular oedema VEGF | placental growth factor | transforming growth factor beta ... View more | 40 | (Responsive group) | iklobbqcuq(tzguayxqqo) = ucbhohvjtq cuhkfaszyt (typyyjeedv ) View more | Positive | 01 Jul 2018 | |
(Unresponsive group) | iklobbqcuq(tzguayxqqo) = xbmqwelgua cuhkfaszyt (typyyjeedv ) View more | ||||||
Phase 3 | 252 | (rnmvxmsnlf) = uqyuscylzq dkmrbyhdug (hhmpingpum ) View more | Positive | 01 Jun 2017 | |||
(Sham) | (rnmvxmsnlf) = hehoamosvi dkmrbyhdug (hhmpingpum ) View more |