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. 2023 Jul-Dec;23(8):851-859.
doi: 10.1080/14712598.2023.2176218. Epub 2023 Feb 19.

Biosimilars for retinal diseases: United States-Europe awareness survey (Bio-USER - survey)

Ashish Sharma  1 , Frank G Holz  2 , Carl D Regillo  3 , K Bailey Freund  4   5 , David Sarraf  6   7 , Arshad M Khanani  8 , Caroline Baumal  9 , Nancy Holekamp  10 , Ramin Tadayoni  11 , Nilesh Kumar  12 , Nikulaa Parachuri  13 , Baruch D Kuppermann  14 ; International Retina Biosimilar Study Group (Inter BIOS Group); 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
Affiliations

Biosimilars for retinal diseases: United States-Europe awareness survey (Bio-USER - survey)

Ashish Sharma et al. Expert Opin Biol Ther. 2023 Jul-Dec.

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.

Keywords: Anti-VEGF; Bio-USER; United States; awareness; biosimilar; europe; ophthalmology; retina; survey.

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