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. 2025 Oct 2.
doi: 10.1038/s41433-025-04030-7. Online ahead of print.

FYB-201 Biosimilar ranibizumab (Ongavia/Ranivisio/Cimerli) Efficacy and Safety in Clinical Settings - FORCE study

Ashish Sharma  1 , Luke Nicholson  2 , Clara Vazquez-Alfageme  3 , Vasuki Sivagnanavel  3 , Riccardo Fausto  3 , Maria Cristina Soare  3 , Marta Bautista Salamanca  4 , Lorenzo Fabozzi  2 , Chrysanthi Tsika  2 , Olga Cejudo Corbalan  4 , Alejandro Gomez Verdejo  4 , Taku Wakabayashi  5 , Se Joon Woo  6 , Anton M Kolomeyer  7   8 , Hana Mansour  9 , Bita Momenaei  9 , Carl D Regillo  9 ; International Retina Biosimilar Study Group (Inter BIOS Group)
Collaborators, Affiliations

FYB-201 Biosimilar ranibizumab (Ongavia/Ranivisio/Cimerli) Efficacy and Safety in Clinical Settings - FORCE study

Ashish Sharma et al. Eye (Lond). .

Abstract

Purpose: To understand the early experience of ranibizumab biosimilar (FYB 201) that has been approved in the United Kingdom (Ongavia, Teva Pharmaceuticals, Tel Aviv Israel), United States (Cimerli, Sandoz Inc, Princeton, NJ, USA) and Europe (Ranivisio, Bioeq AG, Zug, Switzerland).

Methods: 1230 patients received 3595 ranibizumab biosimilar (FYB 201) injections for variable indications in this multicentric retrospective study. All patients were treated with at least one intravitreal injection of ranibizumab biosimilar (FYB 201) 0.5 mg. Primary outcome was best-corrected visual acuity (BCVA). Secondary outcome was central foveal thickness (CFT). Other outcome measures included adverse events.

Results: A total of 3595 ranibizumab biosimilar (FYB 201) injections were given for neovascular age-related macular degeneration (n-AMD) (n = 802), other causes of choroidal neovascularization (CNV) (n = 36), diabetic macular oedema (DMO) (n = 169), retinal vein occlusion (RVO) (n = 155), myopic macular neovascularisation (m-MNV) (n = 61), cystoid macular oedema (CMO) (n = 6) and proliferative diabetic retinopathy (n = 1). Mean age was 77.2 ± 12.7 years and 80.9% were females. The mean follow-up period was 15.7 ± 9.9 weeks after the first injection of ranibizumab biosimilar (FYB 201). Overall, the mean BCVA remained stable from 0.57 ± 0.21 at baseline to 0.56 ± 1.8 at the last follow-up (p = 0.84, 95% CI -0.0915 to 0.1115). The mean CFT was significantly reduced from 260.5 ± 141.8 μm at baseline to 211.4 ± 113.2 μm at the last follow-up (p = 0.0001, 95% CI 38.935 to 59.265). Three eyes (0.24%) had ocular adverse events and 6 patients (0.48%) experienced systemic adverse events during the study period.

Conclusion: Ranibizumab biosimilar (FYB 201) injections were effective and safe in this real-world experience, with stable visual acuity and reduced CFT with no major complications.

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Conflict of interest statement

Competing interests: Ashish Sharma: CONSULTANT: for Novartis, Allergan, Bayer and Intas. Luke Nicholson- None. Clara Vazquez-Alfageme- None. Vasuki Sivagnanavel – None. Riccardo Fausto – None. Maria Cristina Soare – None. Marta Bautista Salamanca – None. Lorenzo Fabozzi- None. Chrysanthi Tsika- None. Olga Cejudo Corbalan – None. Alejandro Gomez Verdejo-None. Hana Mansour- None. Bita Momenaei – None. Taku Wakabayashi- None. Se Joon Woo- Dr Woo reported serving as a consultant for Samsung Bioepis and Panolos Bioscience; being cofounder of Retimark; serving as an advisory board member of Novartis and Novelty Nobility; receiving grants and personal fees from Samsung Bioepis, Novartis, Novelty Nobility, Alteogen, Kookje, and Curacle; and receiving lecture fees from Novartis, Bayer, Allergan, AbbVie, Alcon, Taejoon, SCAI Therapeutics, and Alteogen. Anton M Kolomeyer- -None. Carl D Regillo: Consultant: 4DMT, Adverum, Allergan, Annexon, Apellis, Aviceda, Bausch and Lomb, Clearside, Cognition, EyePoint, Genentech, Iveric, Janssen, Kodiak, Lineage, Merck, NGM, Novartis, Ocugen, Ocuterra, Ocuphire, Opthea, Ray, RegenXBio, Stealth, Thea, Zeiss; Research grant support: 4DMT, Adverum, Allergan, Annexon, Apellis, Astellas, EyePoint, Genentech, Gyroscope, Iveric, Janssen, Kodiak, Lineage, NGM, Notal, Novartis, Ocugen, Ocuterra, Opthea, Regeneron, RegenXBio. Synopsis/Precis: In this preliminary study conducted in clinical settings, the ranibizimab biosimilar (FYB 201) demonstrated efficacy across a range of vascular endothelial growth factor (VEGF)-driven macular disorders. The safety profile of the ranibizumab biosimilar (FYB 201) was observed to be comparable to that of the reference product (Lucentis, Genentech, USA).

References

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