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Biosimilar ranibizumab (BS1) – early experience from Japan (BRIJ study)

Eye volume 38, pages 3193–3196 (2024)Cite this article

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Anti-vascular endothelial growth factor (VEGF) injections are the mainstay of treatment for retinal vascular diseases. However, despite their efficacy, the cost of long term intravitreal injections poses a significant burden on patients and healthcare systems. Recently, ranibizumab biosimilar (ranibizumab BS1, Senju Pharmaceuticals Co Ltd) has become available in Japan [1]. Ranibizumab BS1 is expected to have equivalent efficacy to the originator ranibizumab (0.5 mg) (Lucentis, Genentech, USA) but costs approximately 50% less (85,535 yen/560 USD versus 166,698 yen/1090 USD at the time of approval) per injection. Here, we report the early clinical outcomes regarding safety and efficacy in patients receiving ranibizumab BS1 injections for various retinal diseases. This study is part of the initiative undertaken by the international retina biosimilar study group (Inter BIOS Group).

This was a retrospective study conducted at, Toyama University Hospital, Japan. The primary outcome measure was visual outcomes after ranibizumab BS1 injections, while the secondary outcome measure was adverse events after ranibizumab BS1 injections. Statistical analyses were performed with JMP Pro Software (SAS Inc., Cary, NC, USA) and SigmaStat software version 4.0 (SPSS Inc., Chicago, IL, USA). A P-value of <0.05 was considered statistically significant.

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References

  1. Sharma A, Kondo M, Iwahashi C, Parachuri N, Kumar N, Bandello F, et al. Approved biosimilar ranibizumab-a global update. Eye (Lond). 2023;37:200–2.

    Article  PubMed  Google Scholar 

  2. Sharma A, Holz FG, Regillo CD, Freund KB, Sarraf D, Khanani AM, et al. International Retina Biosimilar Study Group (Inter BIOS Group). Biosimilars for retinal diseases: United States-Europe awareness survey (Bio-USER - survey). Expert Opin Biol Ther. 2023;23:851–9.

    Article  CAS  PubMed  Google Scholar 

  3. Sharma S, Khan MA, Chaturvedi A, RE-ENACT Study Investigators Group. Real-Life clinical effectiveness of Razumab® (the world’s first biosimilar of ranibizumab) in retinal vein occlusion: a subgroup analysis of the pooled retrospective RE-ENACT study. Ophthalmologica. 2019;241:24–31.

    Article  CAS  PubMed  Google Scholar 

  4. Sharma S, Khan MA, Chaturvedi A, RE-ENACT Study Investigators Group. Real life clinical effectiveness of Razumab® (world’s first biosimilar ranibizumab) in wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion: A retrospective pooled analysis. Int J Oph thalmol Eye Res. 2018;6:368–73.

    Google Scholar 

  5. ASRS. Efficacy and safety of biosimilars ranibizumab-nuna and ranibizumab eqrn in clinical use. (2023). https://www.ophthalmologytimes.com/view/asrs-2023-efficacy-and-safety-of-biosimilars-ranibizumab-nuna-and-ranibizumab-eqrn-in-clinical-use.

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Acknowledgements

Ashish Sharma: CONSULTANT: for Novartis, Allergan, Bayer and Intas.

Author information

Authors and Affiliations

  1. Department of Ophthalmology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan

    Tomoko Ueda-Consolvo, Masaaki Ishida, Tomoko Nakamura, Shuichiro Yanagisawa & Atsushi Hayashi

  2. Department of Ophthalmology, Aichi Medical University, Nagakute, Aichi, Japan

    Kotaro Tsuboi

  3. Wakabayashi Eye Clinic, Nonoichi, Ishikawa, Japan

    Taku Wakabayashi

  4. Lotus Eye Hospital and Institute, Avinashi Road, Coimbatore, TN, India

    Ashish Sharma

  5. Gavin Herbert Eye Institute, University of California, Irvine, Irvine, CA, USA

    Baruch D. Kuppermann

  6. Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel

    Anat Loewenstein & Assaf Hilely

  7. University Vita-Salute, Scientific Institute San Raffaele, Milano, Italy

    Francesco Bandello & Giuseppe Querques

  8. Wills Eye Hospital, Mid Atlantic Retina, Thomas Jefferson University, Philadelphia, PA, USA

    Carl D. Regillo

  9. Moorfields Eye Hospital NHS FT, London, UK

    Luke Nicholson, Sobha Sivaprasad, Adnan Tufail & Pearse A. Keane

  10. Royal Eye Unit, Kingston Hospital NHSFT, London, UK

    Clara Vazquez-Alfageme

  11. Madhavi Netralaya, Ara, Bihar, India

    Nilesh Kumar

  12. Department of Vitreoretina, Sankara eye Hospital, Coimbatore, TN, India

    Nikulaa Parachuri

  13. Department of Vitreoretina Shantilal Shanghvi Eye Institute, Mumbai, India

    Jay Sheth

  14. Dr. P. S. Hardia Eye Hospital and Research Center, Indore, India

    Seemantini Ayachit

  15. Trilochan Netralaya, Sambalpur, Odisha, India

    Chitaranjan Mishra

  16. Disha Eye Hosiptal, Kolkata, WB, India

    Debdulal Chakraborty

  17. Banker’s Retina Clinic and Laser Centre, Ahmedabad, India

    Alay Banker

  18. Department of Ophthalmology, Rush University Medical Center, Chicago, IL, USA

    Kourous A. Rezaei

  19. Sierra Eye Associates, Reno, NV, USA

    Arshad M. Khanani

  20. University of Nevada, Reno School of Medicine, Reno, NV, USA

    Arshad M. Khanani

  21. Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA

    Peter K. Kaiser & Aleksandra Rachitskaya

  22. Department of Ophthalmology, Hôpital Lariboisière, AP-HP, Université Paris 7-Sorbonne Paris Cité, Paris, France

    Ramin Tadayoni

  23. Department of Ophthalmology and GRADE Reading Center, University of Bonn, Bonn, Germany

    Frank G. Holz

  24. Stein Eye Institute, UCLA, Los Angeles, CA, USA

    David Sarraf

  25. Department of Ophthalmology, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA

    David Sarraf

  26. Ophthalmology Department, Gazi University School of Medicine, Besevler, Ankara, Turkey

    Şengül Özdek

  27. Department of Ophthalmology, Croix-Rousse University Hospital, Hospices Civils de Lyon, 69004, Lyon, France

    Kodjikian Laurent

  28. UMR5510 MATEIS, CNRS, INSA Lyon, Université de Lyon 1, 69100, Villeurbanne, France

    Kodjikian Laurent

  29. Augen Zentrum Gutenberg AG, 27568, Bern, Switzerland

    Alper Bilgic

  30. Department of Ophthalmology, University of Udine, Udine, Italy

    Paolo Lanzetta & Valentina Sarao

  31. Tufts University School of Medicine, New England Eye Center, Boston, MA, USA

    Caroline Baumal

  32. Roche Pharmaceuticals, Basel, Switzerland

    Nancy Holekemp

  33. Department of Ophthalmology, Kagoshima University, Kagoshima, Japan

    Taiji Sakamoto

  34. Department of Ophthalmology, Bascom Palmer Eye Institute, Miami, FL, USA

    Nicolas Yannuzzi & Jayanth Sridhar

  35. Doheny Eye Institute, Pasadena, CA, USA

    Giulia Corradetti

  36. Retina-Vitreous Associates Medical Group, Los Angeles, CA, USA

    David Boyer

  37. Centre for Public Health, Queen’s University Belfast, Belfast, UK

    Tunde Peto

  38. Department of Ophthalmology, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany

    Maximilian W. M. Wintergerst

  39. Department of Ophthalmology, Sant’Anna Institute, Brescia, Italy

    Barbara Parolini

  40. Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, CA, 94304, USA

    Prithvi Mruthyunjaya, Quan Dong Nguyen & Diana V. DO

  41. Associated Retinal Consultants PC, Royal Oak, MI, USA

    Tarek Hassan

  42. Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA

    Tarek Hassan

  43. Retina Vitreous Associates of Florida, Tampa, FL, USA

    David Eichenbaum

  44. Department of Ophthalmology, Duke University School of Medicine, Durham, NC, USA

    Dilraj S. Grewal

  45. University of Girona, Girona, Spain

    Francesc March

  46. University of Otago, Dunedin, New Zealand

    Francesc March

  47. Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf (UKE), Martinistr. 52, 20246, Hamburg, Deutschland

    Martin Splitzer

  48. Department of Ophthalmology, Bern University Hospital, University of Bern, Freiburgstrasse 15, CH-3010, Bern, Switzerland

    Martin S. Zinkernage

  49. Department for BioMedical Research, University of Bern, Murtenstrasse 24, CH-3008, Bern, Switzerland

    Martin S. Zinkernage

Authors
  1. Tomoko Ueda-Consolvo
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  2. Masaaki Ishida
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  3. Tomoko Nakamura
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  4. Shuichiro Yanagisawa
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  5. Kotaro Tsuboi
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  6. Taku Wakabayashi
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  7. Atsushi Hayashi
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  8. Ashish Sharma
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Consortia

International Retina Biosimilar Study Group (Inter BIOS Group)

  • Baruch D. Kuppermann
  • , Anat Loewenstein
  • , Francesco Bandello
  • , Carl D. Regillo
  • , Luke Nicholson
  • , Clara Vazquez-Alfageme
  • , Nilesh Kumar
  • , Nikulaa Parachuri
  • , Jay Sheth
  • , Seemantini Ayachit
  • , Chitaranjan Mishra
  • , Debdulal Chakraborty
  • , Alay Banker
  • , Kourous A. Rezaei
  • , Arshad M. Khanani
  • , Peter K. Kaiser
  • , Ramin Tadayoni
  • , Frank G. Holz
  • , Sobha Sivaprasad
  • , David Sarraf
  • , Giuseppe Querques
  • , Şengül Özdek
  • , Kodjikian Laurent
  • , Alper Bilgic
  • , Paolo Lanzetta
  • , Caroline Baumal
  • , Nancy Holekemp
  • , Taiji Sakamoto
  • , Adnan Tufail
  • , Nicolas Yannuzzi
  • , Giulia Corradetti
  • , Assaf Hilely
  • , David Boyer
  • , Aleksandra Rachitskaya
  • , Tunde Peto
  • , Maximilian W. M. Wintergerst
  • , Valentina Sarao
  • , Barbara Parolini
  • , Prithvi Mruthyunjaya
  • , Quan Dong Nguyen
  • , Diana V. DO
  • , Pearse A. Keane
  • , Tarek Hassan
  • , Jayanth Sridhar
  • , David Eichenbaum
  • , Dilraj S. Grewal
  • , Francesc March
  • , Martin Splitzer
  •  & Martin S. Zinkernage

Contributions

AS: conception, analysis, drafting, integrity check, final approval. TUC, TW: dta, drafting, revision, analysis, integrity check.

Corresponding author

Correspondence to Ashish Sharma.

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Competing interests

Ashish Sharma: CONSULTANT: for Novartis, Allergan, Bayer and Intas. Tomoko Ueda-Consolvo Masaaki Ishida, Tomoko Nakamura, Shuichiro Yanagisawa, and Taku Wakabayashi: None.

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Cite this article

Ueda-Consolvo, T., Ishida, M., Nakamura, T. et al. Biosimilar ranibizumab (BS1) – early experience from Japan (BRIJ study). Eye 38, 3193–3196 (2024). https://doi.org/10.1038/s41433-024-03220-z

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  • DOI: https://doi.org/10.1038/s41433-024-03220-z

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