https://orcid.org/0000-0002-8550-9791
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ABSTRACT
Purpose
To assess the awareness of biosimilar intravitreal anti-VEGF agents among retina specialists practicing in the United States (US) and Europe.
Methods
A 16-question online survey was created in English and distributed between Dec 01, 2021 and Jan 31, 2022. A total of 112 respondents (retinal physicians) from the US and Europe participated.
Results
The majority of the physicians (56.3%) were familiar with anti-VEGF biosimilars. A significant number of physicians needed more information (18.75%) and real world data (25%) before switching to a biosimilar. About one half of the physicians were concerned about biosimilar safety (50%), efficacy (58.9 %), immunogenicity (50%), and their efficacy with extrapolated indications (67.8 %). Retinal physicians from the US were less inclined to shift from off-label bevacizumab to biosimilar ranibizumab or on-label bevacizumab (if approved) compared to physicians from Europe (p=0.0001). Furthermore, physicians from the US were more concerned about biosimilar safety (p=0.0371) and efficacy compared to Europe (p= 0.0078).
Conclusions
The Bio-USER survey revealed that while the majority of retinal physicians need additional information regarding the safety, efficacy and immunogenicity when making clinical decisions regarding their use. Retinal physicians from US are more comfortable in continuing to use off-label bevacizumab compared to physicians from Europe.
Acknowledgments
We would like to acknowledge the following colleagues for helping us with this survey; Daniele Veritti, Thibaud Mathis, Stephanie Lu, Sean Tsao, Mitul Mehta, Sumit Sharma, Dilraj Grewal, Narcisa Ianopol, Farid Thomaz, Peter Clark, Andrew Browne, Sayena Jebbehdari. Bio-USER survey data was presented in parts at EURETINA 2022 (Hamburg) and AAO 2022 (Chicago).
International Retina Biosimilar Study Group (Inter BIOS Group)
Francesco Bandello, Giuseppe Querques, Anat Loewenstein, Şengül Özdek, Kourous Rezai, Kodjikian Laurent, Alper Bilgic, Paolo Lanzetta, Dinah Zur, Nicolas Yannuzzi, Giulia Corradetti, Peter Kaiser, Assaf Hilely, David Boyer, Aleksandra Rachitskaya, Usha Chakravarthy, Maximilian Wintergerst, Valentina Sarao, Barbara Parolini, Prithvi Mruthyunjaya, Quan Dong Nguyen, Diana DO, Pearse A Keane, Tarek Hassan, Jayanth Sridhar, David Eichenbaum, Dilraj Grewal, Martin Splitzer
Declaration of interest
A Sharma is a consultant for Intas, Novartis, Bayer, Allergan and Lupin.
FG Holz reports research grants and personal fees from Acucel, Allergan, Apellis, Bayer, Bioeq/Formycon, Roche/Genentech, Geuder, Heidelberg Engineering, ivericBio, Pixium Vision, Novartis and Zeiss; and personal fees from Alexion, Grayburg Vision, LinBioscience, Stealth BioTherapeutics, Aerie and Oxurion.
CD Regillo is a consultant for Adverum, Allergan, Annexon, Bausch and Lomb, Clearside, Eyepoint, Genentech/Roche, Iveric, Novartis, Kodiak, Notal, Merck, Ocular therapeutics, Regenxbio, Stealth, Takeda, Zeiss and receives research support from Adverum, Allergan, Annexon, Eyepoint, Genentech/Roche, Novartis, Kodiak, Iveric, Regenxbio, Regeneron.
KB Freund is a consultant for Heidelberg Engineering, Zeiss, Genentech, Bayer, Novartis, and Allergan. He receives research support from Genentech/Roche.
David Sarraf is a consultant for Amgen, Bayer, Endogena Therapeutics, Genentech, Iveric Bio, Novartis, and Optovue/Visionix and receives research grants from Amgen, Boehringer, Genentech, Heidelberg, Optovue/Visionix, Regeneron, and Topcon.
AM Khanani is a consultant for Adverum, Aerpio, Alimera, Allergan, Apellis, Asclepix, Aviceda, Bausch, and Lomb, Broadwing Bio, Chengdu Kanghong, Cholgene, 4DMT, Dutch Ophthalmic Research Center, Gemini, Genentech, Glaukos, Graybug, Gyroscope, Iveric Bio, Janssen, Kato Pharma, Kodiak, Oculis, Opthea, Oxurion, Novartis, Pollphotonix, Recens Medical, Regeneron, Retrotope, Regenxbio, Roche, Surrozen, Thea, and Unity Bio. He has received research support from Adverum, Apellis, Asclepix, Chengdu Kanghong, 4DMT, Gemini, Genentech, Graybug Vision, Gyroscope, Iveric Bio, Kodiak, Neurotech, NGM Bio, Ocular Therapeutix, Oculis, Opthea, Oxurion, Novartis, Recens Medical, Regerxbio, Roche, and Unity Bio. He has received equity from Aviceda, Gyroscope, Recens Medical, Retrotope, and Pollphotonix and has acted as a speaker for Allergan, Genentech and Novartis.
C Baumal is a consultant for Genentech, Novartis, Ora, and Apellis and has been a speaker for Regeneron.
N Holekamp has received consulting fees from 4DMT. AGTC, Abbvie/Allergan, Annexon, Apellis, Bayer, Biogen, Boehringer, Cardinal, Clearside Biosciences, EyePoint Pharmaceuticals, Genentech, Gyroscope, Medpace, Medscape, Nacuity, NGM, Notal Vision, Novartis, Ocuphire, Outlook Therapeutics, Regeneron, Roche, Thea Laboratoires, Stealth Biosciences, Vial Speakers Bureau: Abbvie, Apellis, Genentech, Regeneron, Bausch and Lomb Contracted Research: Genentech, Gemini, Gyroscope, Notal Vision Data Monitoring and Safety Committee: Editas, Ocuphire, Roche Stock or Stock options: Apellis, Notal Vision Employee: Roche ”Visiting Professor”.
R Tadayoni is a consultant for AbbVie, Allergan, Alcon, Apellis, Bayer, Boehringer Ingelheim, Genentech, Iveric Bio, KHB, Novartis, Oculis, Roche, Thea, and Zeiss.
BD Kuppermann has conducted clinical research for Alcon, Alimera, Allegro, Allergan, Apellis, Clearside, Genentech, GSK, Ionis, jCyte, Novartis, Regeneron, and ThromboGenics. He is a consultant for Alimera, Allegro, Allergan, Cell Care, Dose, Eyedaptic, Galimedix, Genentech, Glaukos, Interface Biologics, jCyte, Novartis, Ophthotech, Regeneron, Revana, and Theravance Biopharma. He also acknowledges an unrestricted grant from Research to Prevent Blindness to the Gavin Herbert Eye Institute at the University of California, Irvine.
The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Ethics
The survey did not require any medical record review or patient interaction therefore institutional review board approval was not required. Consent was obtained from participants after informing them about the purpose of the survey and how their responses would be used with the protection of confidential information.
Author contributions
A Sharma: conception, analysis, drafting, integrity check, final approval. FG Holz, CD Regillo, KB Freund, D Sarraf, AM Khanani, C Baumal, N Holekamp, R Tadayoni, N Kumar, N Parachuri, BD Kupperman: review, drafting, editing, revision, integrity check. Other Inter BIOS Group members: review.