Ranibizumab biosimilars: real-world and switching evidence
What the evidence shows
- Studies found2 studies, both from eye clinics in routine care. No randomised switching trial for ranibizumab is in this register.
- What the clinics foundIn Birmingham, 92 eyes were moved from Lucentis to Ongavia; six months later injection intervals had been kept or extended in 74 in 100 of the wet AMD eyes, and 1 in 10 were moved to another drug for poor response. In a Swiss clinic, 31 patients moved from Lucentis to Byooviz; disease activity stayed stable in 7 in 10 eyes, and vision worsened in 4 in 10.
- Products with evidenceByooviz, Ongavia. No published switching study yet in this register for Cimerli, Ximluci or the Indian products, including Razumab.
- What is missingNo study from India or the Gulf. Both studies are small and single-centre. Nothing with a control group kept on Lucentis, and nothing beyond a year.
Studies
Trials and extensions with a single switch
Patients on Lucentis in a trial were moved once to the biosimilar, usually at the half-way point, and followed alongside those who stayed.
| Study | Disease | Switch | Products | Patients switched | Follow-up | What the authors report |
|---|---|---|---|---|---|---|
| Said 2026 Klin Monbl Augenheilkd 2026;243(4):434-439 Augenklinik Wettingen, Switzerland (single centre) | Neovascular age-related macular degeneration (61.3%), macular oedema after retinal vein occlusion (22.6%), diabetic macular oedema (9.7%), secondary choroidal neovascularisation (6.5%) | Originator to biosimilar | Byooviz | 31 | Median 8 Byooviz injections after the switch | Visual acuity improved in 8 eyes (25.8%), unchanged in 10 (32.3%) and worsened in 13 (41.9%); disease activity decreased in 6 eyes (20%), increased in 3 (10%) and stable in 22 (70%); treatment intervals shortened in 8 patients (25.8%) and extended in 14 (45.2%); no endophthalmitis or other complications. |
| Sourla 2026 Cureus 2026;18(1):e101850 Birmingham and Midland Eye Centre, UK (single centre) | Neovascular age-related macular degeneration (90 eyes), diabetic macular oedema (1) and macular oedema after retinal vein occlusion (1) | Originator to biosimilar | Ongavia | 92 | 6 months | Of 87 wet AMD eyes with more than two Ongavia injections, injection intervals were maintained or extended in 64 (73.5%), reduced in 7 (8%), and 9 eyes (10.3%) were moved to another anti-VEGF for poor response; no ocular side effects documented; patient satisfaction with the information process 100%. |
Visual acuity improved in 8 eyes (25.8%), unchanged in 10 (32.3%) and worsened in 13 (41.9%); disease activity decreased in 6 eyes (20%), increased in 3 (10%) and stable in 22 (70%); treatment intervals shortened in 8 patients (25.8%) and extended in 14 (45.2%); no endophthalmitis or other complications.
Of 87 wet AMD eyes with more than two Ongavia injections, injection intervals were maintained or extended in 64 (73.5%), reduced in 7 (8%), and 9 eyes (10.3%) were moved to another anti-VEGF for poor response; no ocular side effects documented; patient satisfaction with the information process 100%.
No study matches this selection.
Switching evidence is what regulators, tender committees and formulary boards ask for before a change of product. EvySaif prepares interchangeability and switching dossiers and designs real-world studies for biosimilar programmes. Regulatory strategy consulting
Sources
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