LAUSR

Retina as a subspecialty has transformed since the introduction of anti-vascular endothelial growth factor (anti-VEGF) therapeutics more than a decade ago. Approved intravitreal anti-VEGF agents such as ranibizumab (2006) and aflibercept (2011) have made a significant impact on the visual outcomes of various retinal vascular and choroidal neovascular diseases along with off-label intravitreal bevacizumab [1, 2]. Newer anti-VEGF molecules such as brolucizumab (2019) have been approved in the recent past; however, their use has been limited due to higher rates of inflammation and associated retinovascular complications [3, 4]. Recently, port delivery system (PDS) with ranibizumab received United States Food and Drug Administration (US-FDA) approval as the first sustained-release, long-acting anti-VEGF therapy platform [5]. Faricimab, an intravitreal bispecific antibody that targets both VEGF and angiopoietin 2, has also received US-FDA approval recently [6]. The patents for ranibizumab expired in 2020 and that of aflibercept by 2023 [7]. The expiry of patents has opened up an era of intravitreal anti-VEGF biosimilars [8]. US-FDA and European Medical Agency (EMA) have approved the first biosimilar of ranibizumab in the recent past [9]. India was the first country to approve a biosimilar of ranibizumab (2015) [10]. At least 20 biosimilar molecules of ranibizumab, aflibercept, and bevacizumab are in the pipeline [7]. Although biosimilars are new to ophthalmology, they have been successfully used in other subspecialties such as rheumatology, dermatology, gastroenterology, oncology, and hematology [11]. This article will highlight how retina is a unique landscape for biosimilars.