Real-World Analysis of Switching Between Ranibizumab Biosimilars: Safety and Results - a Multicenter Retrospective Observational Study
In brief
Two-thirds of eyes improved by at least 2 lines after biosimilar switches
In a real-world Indian cohort of 595 eyes that underwent one or two availability-driven switches between ranibizumab biosimilars, 62% gained at least two lines of vision and 82% maintained or improved acuity over 24 weeks, with central macular thickness halving and no recorded serious ocular adverse events.
- Journal
- Clinical ophthalmology (Auckland, N.Z.) (Q1)
- Published
- 15 September 2026
- Study design
- Retrospective cohort
- Evidence level
- Level 3, Low (CEBM 3b)
- Authors
- Debdulal Chakraborty, Tushar Kanti Sinha, Rupak Kanti Biswas, Aniruddha Maiti, Manab Jyoti Barman, Ranabir Bhattacharya, et al.
- PMID
- 42763736
- DOI
- 10.2147/OPTH.S624886
Why clinicians should know about it
- Picked for Ophthalmology (paper of the day, 23 September 2026): Real‑world switching of ranibizumab biosimilars in retina practice
Abstract
PURPOSE: To describe disease-specific visual, anatomical, treatment-exposure, and documented safety outcomes over 24 weeks among eyes undergoing availability-driven switching between ranibizumab biosimilars in routine retinal practice in India. METHODS: This multicenter retrospective observational cohort study reviewed records from January to December 2024. Baseline was the index-switch visit, before administration of the substituted ranibizumab biosimilar. Only one eye per patient was included; when both eyes were eligible, the right eye was selected by convention. Eligible eyes had at least one documented availability-driven biosimilar-to-biosimilar switch and complete 24-week follow-up. Outcomes were summarized descriptively because there was no non-switch comparator group. RESULTS: Of 742 screened eyes, 595 eyes from 595 patients met the inclusion criteria and received 1625 intravitreal ranibizumab biosimilar injections over 24 weeks (mean, 2.73 injections per eye). One switch was recorded in 466 eyes (78.3%) and two switches in 129 eyes (21.7%). Mean BCVA improved from 0.57 logMAR at baseline to 0.26 at 12 weeks and 0.32 at 24 weeks; the early visual improvement therefore attenuated modestly by week 24 but remained better than baseline. Mean central macular thickness decreased from 490.4 micrometers at baseline to 273.6 micrometers at 24 weeks. At final follow-up, 369 eyes (62.0%) gained at least two lines and 488 eyes (82.0%) maintained or improved vision. No endophthalmitis, retinal detachment, or treatment-related systemic adverse event was documented in the available clinical records. CONCLUSION: Eyes exposed to availability-driven switching between ranibizumab biosimilars showed favorable short-term visual and anatomical outcomes over 24 weeks. Because this retrospective study lacked a non-switch comparator and protocol-mandated safety or immunogenicity surveillance, it cannot establish an effect attributable to switching, comparative safety, equivalence, or formal interchangeability.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.