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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Acknowledgements
Ashish Sharma: CONSULTANT: for Novartis, Allergan, Bayer and Intas.
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Authors and Affiliations
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
Department of Ophthalmology, Aichi Medical University, Nagakute, Aichi, Japan
Kotaro Tsuboi
Wakabayashi Eye Clinic, Nonoichi, Ishikawa, Japan
Taku Wakabayashi
Lotus Eye Hospital and Institute, Avinashi Road, Coimbatore, TN, India
Ashish Sharma
Gavin Herbert Eye Institute, University of California, Irvine, Irvine, CA, USA
Baruch D. Kuppermann
Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel
Anat Loewenstein&Assaf Hilely
University Vita-Salute, Scientific Institute San Raffaele, Milano, Italy
Francesco Bandello&Giuseppe Querques
Wills Eye Hospital, Mid Atlantic Retina, Thomas Jefferson University, Philadelphia, PA, USA
Carl D. Regillo
Moorfields Eye Hospital NHS FT, London, UK
Luke Nicholson,Sobha Sivaprasad,Adnan Tufail&Pearse A. Keane
Royal Eye Unit, Kingston Hospital NHSFT, London, UK
Clara Vazquez-Alfageme
Madhavi Netralaya, Ara, Bihar, India
Nilesh Kumar
Department of Vitreoretina, Sankara eye Hospital, Coimbatore, TN, India
Nikulaa Parachuri
Department of Vitreoretina Shantilal Shanghvi Eye Institute, Mumbai, India
See AlsoMost Seasons With Over 300 Pitching Strikeouts | StatMuseBílá světla do bazénu | Plavte.czConstruction des appareils électroniques du débutantJay Sheth
Dr. P. S. Hardia Eye Hospital and Research Center, Indore, India
Seemantini Ayachit
Trilochan Netralaya, Sambalpur, Odisha, India
Chitaranjan Mishra
Disha Eye Hosiptal, Kolkata, WB, India
Debdulal Chakraborty
Banker’s Retina Clinic and Laser Centre, Ahmedabad, India
Alay Banker
Department of Ophthalmology, Rush University Medical Center, Chicago, IL, USA
Kourous A. Rezaei
Sierra Eye Associates, Reno, NV, USA
Arshad M. Khanani
University of Nevada, Reno School of Medicine, Reno, NV, USA
Arshad M. Khanani
Cole Eye Institute, Cleveland Clinic, Cleveland, OH, USA
Peter K. Kaiser&Aleksandra Rachitskaya
Department of Ophthalmology, Hôpital Lariboisière, AP-HP, Université Paris 7-Sorbonne Paris Cité, Paris, France
Ramin Tadayoni
Department of Ophthalmology and GRADE Reading Center, University of Bonn, Bonn, Germany
Frank G. Holz
Stein Eye Institute, UCLA, Los Angeles, CA, USA
David Sarraf
Department of Ophthalmology, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA
David Sarraf
Ophthalmology Department, Gazi University School of Medicine, Besevler, Ankara, Turkey
Şengül Özdek
Department of Ophthalmology, Croix-Rousse University Hospital, Hospices Civils de Lyon, 69004, Lyon, France
Kodjikian Laurent
UMR5510 MATEIS, CNRS, INSA Lyon, Université de Lyon 1, 69100, Villeurbanne, France
Kodjikian Laurent
Augen Zentrum Gutenberg AG, 27568, Bern, Switzerland
Alper Bilgic
Department of Ophthalmology, University of Udine, Udine, Italy
Paolo Lanzetta&Valentina Sarao
Tufts University School of Medicine, New England Eye Center, Boston, MA, USA
Caroline Baumal
Roche Pharmaceuticals, Basel, Switzerland
Nancy Holekemp
Department of Ophthalmology, Kagoshima University, Kagoshima, Japan
Taiji Sakamoto
Department of Ophthalmology, Bascom Palmer Eye Institute, Miami, FL, USA
Nicolas Yannuzzi&Jayanth Sridhar
Doheny Eye Institute, Pasadena, CA, USA
Giulia Corradetti
Retina-Vitreous Associates Medical Group, Los Angeles, CA, USA
David Boyer
Centre for Public Health, Queen’s University Belfast, Belfast, UK
Tunde Peto
Department of Ophthalmology, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany
Maximilian W. M. Wintergerst
Department of Ophthalmology, Sant’Anna Institute, Brescia, Italy
Barbara Parolini
Spencer Center for Vision Research, Byers Eye Institute, Stanford University, Palo Alto, CA, 94304, USA
Prithvi Mruthyunjaya,Quan Dong Nguyen&Diana V. DO
Associated Retinal Consultants PC, Royal Oak, MI, USA
Tarek Hassan
Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA
Tarek Hassan
Retina Vitreous Associates of Florida, Tampa, FL, USA
David Eichenbaum
Department of Ophthalmology, Duke University School of Medicine, Durham, NC, USA
Dilraj S. Grewal
University of Girona, Girona, Spain
Francesc March
University of Otago, Dunedin, New Zealand
Francesc March
Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf (UKE), Martinistr. 52, 20246, Hamburg, Deutschland
Martin Splitzer
Department of Ophthalmology, Bern University Hospital, University of Bern, Freiburgstrasse 15, CH-3010, Bern, Switzerland
Martin S. Zinkernage
Department for BioMedical Research, University of Bern, Murtenstrasse 24, CH-3008, Bern, Switzerland
Martin S. Zinkernage
Authors
- Tomoko Ueda-Consolvo
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- Masaaki Ishida
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- Tomoko Nakamura
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- Shuichiro Yanagisawa
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- Kotaro Tsuboi
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- Taku Wakabayashi
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- Atsushi Hayashi
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- 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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Ueda-Consolvo, T., Ishida, M., Nakamura, T. et al. Biosimilar ranibizumab (BS1) – early experience from Japan (BRIJ study). Eye (2024). https://doi.org/10.1038/s41433-024-03220-z
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DOI: https://doi.org/10.1038/s41433-024-03220-z
