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

生物仿制药 视网膜 医学 业务 眼科 内科学
作者
Ashish Sharma,Frank G. Holz,Carl D. Regillo,K. Bailey Freund,David Sarraf,Arshad M. Khanani,Caroline R. Baumal,Nancy M. Holekamp,Ramin Tadayoni,Nilesh Kumar,Nikulaa Parachuri,Baruch D. Kuppermann,Francesco Bandello,Giuseppe Querques,Anat Loewenstein,Şengül Özdek,Kourous A. Rezai,Kodjikian Laurent,Alper Bilgic,Paolo Lanzetta,Dinah Zur,Nicolas A. Yannuzzi,Giulia Corradetti,Peter K. Kaiser,Assaf Hilely,David S. Boyer,Aleksandra Rachitskaya,Usha Chakravarthy,Maximilian W. M. Wintergerst,Valentina Sarao,Barbara Parolini,Prithvi Mruthyunjaya,Quan Dong Nguyen,Diana Do,Pearse A. Keane,T. Hassan,Jayanth Sridhar,David Eichenbaum,Dilraj S. Grewal,Martin Splitzer
出处
期刊:Expert Opinion on Biological Therapy [Taylor & Francis]
卷期号:23 (8): 851-859 被引量:10
标识
DOI:10.1080/14712598.2023.2176218
摘要

To assess the awareness of biosimilar intravitreal anti-VEGF agents among retina specialists practicing in the United States (US) and Europe.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.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).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.

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