Table 1.
Key characteristics of phase 3 clinical trial designs.
| Biosimilar name/ manufacturing company | Approval indications | Sample size | Primary outcome | Marketed by/brand name | Total study duration | Safety assessment criteria |
|---|---|---|---|---|---|---|
| Razumab/ Intas Pharmaceuticals Ltd, Ahmedabad, GJ | n-AMD, DMO, RVO, m-CNVM, PDR, ROP |
104 (Razumab-78) (RBZ-26) |
Loss of < 15 letters on ETDRS at 12 weeks. | Intas Pharmaceuticals/ RAZUMAB | 3 months |
TEAEs ADA |
| Ranizurel/Reliance Life Sciences Mumbai, MH | n-AMD |
160 (Ranizurel-107) (RBZ-53) |
Loss of < 15 letters on ETDRS at 16 weeks. |
Reliance Life Sciences/ RANIZUREL Cipla Ltd/ VISUMAB |
6 months |
TEAEs ADA |
| Ranieyes/ Lupin Ltd, Mumbai, MH | n-AMD, DMO, RVO, m-CNVM, PDR |
202 (Ranieyes-101) (RBZ-101) |
Loss of < 15 letters on ETDRS at 12 weeks. |
Lupin Ltd/ RANIEYES Sun Pharmaceuticals/ OCEVA |
3 months |
TEAEs ADA |
| Optimab/ Enzene Biosciences a subsidiary of Alkem Labs, Pune, MH | n-AMD |
152 (Optimab-114) (RBZ-38) |
Loss of < 15 letters on ETDRS at 12 weeks. |
Alkem Labs/ OPTIMAB Ipca Labs/PREVISION Mankind Pharma/RETIZUBA |
3 months |
TEAEs ADA |
Key characteristics of phase 3 clinical trial designs of ranibizumab manufacturers approved by DCGI.
n-AMD neovascular age-related macular degeneration, DMO diabetic macular oedema, RVO retinal vein occlusion, m-CNVM myopic choroidal neovascular membrane, PDR proliferative diabetic retinopathy, ROP retinopathy of prematurity.
DCGI Drug Controller General of India, BCVA best Corrected Visual Acuity, ETDRS Early Treatment Diabetic Retinopathy Study Letters, TEAEs Treatment-Emergent Adverse Events, ADA Anti Drug Antibodies, RBZ Reference ranibizumab, NA Not Available.