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

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

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

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)