Table 1 Key characteristics of phase 3 clinical trial design.
Biosimilar name | Approval authority (date) | Sample size | Primary outcome | Equivalence margin | Total study duration | Safety assessment criteria |
|---|---|---|---|---|---|---|
Byooviz/Ranibizumab-nuna (SB11) | US-FDA and EMA | 705 (SB11-351) (RBZ-354) | BCVA improvement (8 weeks) CST (4 weeks) | BCVA (−3 to +3 ETDRS letters) CST (−36 to +36 μm) | 12 months | TEAEs ADA |
Ongavia (FYB 201) CIMERLI/Ranibizumab-eqrn (FYB 201) Ranivisio (FYB 201) | UKMHRA US-FDA EMA | 477 (FYB 201-238) (RBZ-239) | BCVA improvement (8 weeks) | BCVA (−3.5 to +3.5 ETDRS letters) | 12 months | TEAEs ADA |
Ranibizumab Biosimilar 1 (Ranibizumab-BS1) | Japan Ministry of Health, Labour and Welfare (Japan) | 351 (Ranibizumab BS 1-176) (RBZ-175) | BCVA improvement (12 weeks) | BCVA (−4 to +4 ETDRS letters) | 12 months | TEAEs ADA |
Razumab | DCGI India | 104 (Razumab-78) (RBZ-26) | Loss of <15 letters on ETDRS at 12 weeks | NA | 3 months | TEAEs ADA |
Ranizurel | DCGI India | 160 (Ranizurel-107) (RBZ-53) | Loss of <15 letters on ETDRS at 16 weeks | NA | 6 months | TEAEs ADA |
Ranieyes | DCGI India | 202 (Ranieyes-101) (RBZ-101) | Loss of <15 letters on ETDRS at 12 weeks | ±8.5% | 3 months | TEAEs ADA |
