Biosimilars in diabetic macular edema: Promise, progress, and pitfalls. (PubMed, Indian J Ophthalmol) - Oct 3, 2026 - "Following the expiration of patents for agents such as aflibercept and ranibizumab, several biosimilars have been developed, approved, and introduced into clinical practice. Evidence from real-world studies-including RE-ENACT2 (REal-life assessmENt of safety And effeCTiveness of Razumab) and REAR-RD2 (REal-world observational study to evaluate the risk factors in the management of REtinal Diseases-2)-as well as randomized clinical trials such as INSIGHT and CT-P42 has demonstrated clinical equivalence between these biosimilars and their reference anti-VEGF counterparts in the treatment of DME. This article provides an updated overview of the current evidence base, recent advances in regulatory pathways, and ongoing challenges in integrating biosimilars into routine DME management."
Clinical • Journal • Review • Diabetes • Diabetic Macular Edema • Metabolic Disorders • Ophthalmology • Retinal Disorders
|
|
De-Kuang Hwang; Manoj P Shettigar; Sibel Demirel; Vanaja Jain; Vivek P Dave
|