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Purpose <p>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).</p> Methods <p>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&#xa0;(CFT). Other outcome measures included adverse events.</p> Results <p>A total of 3595 ranibizumab biosimilar (FYB 201) injections were given for neovascular age-related macular degeneration (n-AMD) (<i>n</i> = 802), other causes of choroidal neovascularization (CNV) (<i>n</i> = 36), diabetic macular oedema (DMO) (<i>n</i> = 169), retinal vein occlusion (RVO) (<i>n</i> = 155), myopic macular neovascularisation (m-MNV) (<i>n</i> = 61), cystoid macular oedema (CMO) (<i>n</i> = 6) and proliferative diabetic retinopathy (<i>n</i> = 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 (<i>p</i> = 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 (<i>p</i> = 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.</p> Conclusion <p>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.</p>

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

  • 期刊论文

  • 发表日期：

    2025年10月2日

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  • Ashish Sharma,
  • Luke Nicholson,
  • Clara Vazquez-Alfageme,
  • Vasuki Sivagnanavel,
  • Riccardo Fausto,
  • Maria Cristina Soare,
  • Marta Bautista Salamanca,
  • Lorenzo Fabozzi,
  • Chrysanthi Tsika,
  • Olga Cejudo Corbalan,
  • Alejandro Gomez Verdejo,
  • Taku Wakabayashi,
  • Se Joon Woo,
  • Anton M. Kolomeyer,
  • Hana Mansour,
  • Bita Momenaei,
  • Carl D. Regillo,
  • Baruch D. Kuppermann,
  • Anat Loewenstein,
  • Francesco Bandello,
  • Giuseppe Querques,
  • Tomoko Ueda-Consolvo,
  • Masaaki Ishida,
  • Tomoko Nakamura,
  • Shuichiro Yanagisawa,
  • Atsushi Hayashi,
  • Kotaro Tsuboi,
  • Nilesh Kumar,
  • Nikulaa Parachuri,
  • Jay Sheth,
  • Seemantini Ayachit,
  • Chitaranjan Mishra,
  • Debdulal Chakraborty,
  • Alay Banker,
  • Kourous A. Rezaei,
  • Arshad M. Khanani,
  • Peter K. Kaiser,
  • Frank G. Holz,
  • Sobha Sivaprasad,
  • Şengül Özdek,
  • Kodjikian Laurent,
  • Alper Bilgic,
  • Paolo Lanzetta,
  • Valentina Sarao,
  • Caroline Baumal,
  • Nancy Holekemp,
  • Taiji Sakamoto,
  • Adnan Tufail,
  • Nicolas Yannuzzi,
  • Jayanth Sridhar,
  • Giulia Corradetti,
  • Assaf Hilely,
  • David Boyer,
  • Aleksandra Rachitskaya,
  • Tunde Peto,
  • Maximilian W. M. Wintergerst,
  • Barbara Parolini,
  • Prithvi Mruthyunjaya,
  • Quan Dong Nguyen,
  • Diana V. DO,
  • Pearse A. Keane,
  • Tarek Hassan,
  • David Eichenbaum,
  • Dilraj S. Grewal,
  • Francesc March,
  • Martin S. Spitzer,
  • Khalil G. Falavarjani,
  • Martin S. Zinkernagel,
  • Christopher Seungkyu Lee,
  • Judy E. Kim

摘要

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.