Drug Design, Development and Therapy (Feb 2024)
Ranibizumab Biosimilars in Treating Retinal Disorders: A Cost-Effective Revolution?
Abstract
Eleftherios Chatzimichail,1 Kristina Pfau,1,2 Zisis Gatzioufas,1 Georgios D Panos3,4 1Department of Ophthalmology, University Hospital of Basel, Basel, Switzerland; 2Department of Ophthalmology, University Hospital Bonn, Bonn, Germany; 3Department of Ophthalmology, Queen’s Medical Centre, Nottingham University Hospitals, Nottingham, UK; 4Division of Ophthalmology and Visual Sciences, School of Medicine, University of Nottingham, Nottingham, UKCorrespondence: Georgios D Panos, Department of Ophthalmology, Queen’s Medical Centre, Derby Road, Lenton, Nottingham, NG7 2UH, UK, Tel +44 115 924 9924, Email [email protected]: Ranibizumab, is a humanized, monoclonal antibody fragment that binds and inactivates vascular endothelial growth factor-A (VEGF-A) and VEGF-B. One of the main indications for an intravitreal treatment with ranibizumab is age-related macular degeneration (AMD), which is a retinal disease with a high worldwide socioeconomic impact. Biosimilars constitute biological products that demonstrate similar pharmacodynamic and pharmacokinetic characteristics with a reference product, as well as comparable clinical efficacy, safety and immunogenicity. Since the approval of the first biosimilar Razumab, there has been a variety of new biosimilars available on the market. They offer the advantage of the same good clinical and safety results at a better price. All Ranibizumab biosimilars that have gained approval were tested in double masked Phase 3 clinical studies. The use of Ranibizumab biosimilars in neovascular AMD is well reported in the bibliography. Nevertheless, over the last few years, there is a tendency of using biosimilars in other retinal diseases like retinopathy of prematurity (ROP), diabetic macular edema (DME) or polypoidal choroidal vasculopathy (PCV). In conclusion, ranibizumab biosimilars offer a promising avenue for the management of retinal diseases, especially in countries with lower socioeconomic status, where there is lack of availability of innovator ranibizumab. However, further research is required to fully explore their efficacy, safety, and long-term outcomes in a plethora of retinal diseases.Keywords: ranibizumab, biosimilars, age-related macular degeneration, diabetic macular edema, retinal disorders, retinal vein occlusion, cost-effectiveness
