Evidence map›Paper›PMID 40170980›Full record

ArticleClinical ophthalmology (Auckland, N.Z.)2025

CompaRative Safety Analysis of Innovator and BioSimilar Ranibizumab in Chorioretinal Vascular Diseases - The CRsIBS Study.

Debdulal Chakraborty, Tushar Kanti Sinha, Sourav Sinha, Rupak Kanti Biswas, Aniruddha Maiti, Subhendu Boral, Arnab Das, Soumava Mandal, Ranabir Bhattacharya, Shouvick Dan and 1 more

Abstract read
In one paragraph

Article in Clinical ophthalmology (Auckland, N.Z.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Anti-vascular endothelial growth factor conundrum.Indian journal of ophthalmology · 2026
    Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Debdulal ChakrabortyDepartment of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India.ORCID 0000-0001-9693-7882
Tushar Kanti SinhaDepartment of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India.
Sourav SinhaDepartment of Vitreoretinal Services, Netralayam Superspeciality Eye Care, Kolkata, West Bengal, India.
Rupak Kanti BiswasDepartment of Vitreoretinal Services, Netralayam Superspeciality Eye Care, Kolkata, West Bengal, India.
Aniruddha MaitiDepartment of Vitreoretinal Services, Global Eye Hospitals, Kolkata, West Bengal, India.
Subhendu BoralDepartment of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India.ORCID 0000-0002-8656-8339
Arnab DasDepartment of Vitreoretinal Services, Netralayam Superspeciality Eye Care, Kolkata, West Bengal, India.
Soumava MandalDepartment of Vitreoretinal Services, Susrut Eye Foundation and Research Centre, Kolkata, West Bengal, India.
Ranabir BhattacharyaDepartment of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India.
Shouvick DanDepartment of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India.
Dinesh RungtaDepartment of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To compare the safety profiles of biosimilar ranibizumab (Razumab™) and innovator ranibizumab (Accentrix™) in the management of chorioretinal vascular diseases across a large, diverse patient cohort in a multicenter retrospective study. Methods: This multicenter, retrospective study analyzed data from 39,226 eyes treated with either biosimilar or innovator ranibizumab across 21 centers in India between January 2016 and March 2024. Eligible patients received intravitreal injections for conditions including age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and myopic choroidal neovascularization (CNVM). Patients were followed for a minimum of three months, with adverse events documented during follow-up visits. Safety outcomes were assessed based on ocular and systemic adverse events, with statistical analyses comparing frequencies between groups using chi-square and t-tests. Results: A total of 46,520 injections were administered in the innovator group (20,283 eyes; mean 2.29±1.53 injections per eye) and 45,310 injections in the biosimilar group (18,943 eyes; mean 2.39±1.61 injections per eye). Both groups showed comparable safety profiles. Ocular adverse events were mostly mild, with similar rates of transient blurring, subconjunctival hemorrhage, and ocular pain. Serious ocular events, including endophthalmitis, were rare (2 cases in each group). Systemic adverse events, such as myocardial infarction and cerebrovascular accidents, were also rare, with no statistically significant differences between groups. A higher incidence of anterior chamber inflammation was noted in the biosimilar group (p=0.005), while headache was significantly more common in this group (p=0.0002). Conclusion: This large-scale real-world study demonstrates that biosimilar ranibizumab offers a comparable safety profile to innovator ranibizumab in the management of chorioretinal vascular diseases. The affordability of biosimilar ranibizumab enhances its potential as a cost-effective alternative, particularly in resource-limited settings, without compromising safety.

Indexed as

anti VEGFbiosimilar ranibizumabchorio-retinal vascular diseaseranibizumab

Identifiers

PMID40170980
PMCPMC11960473

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.