Biosimilars of anti-vascular endothelial growth factor for ophthalmic diseases: A review

• Published in: Survey of ophthalmology 2024-07, Vol.69 (4), p.521-538
• Main Authors: Bressler, Neil M., Kaiser, Peter K., Do, Diana V., Nguyen, Quan Dong, Park, Kyu Hyung, Woo, Se Joon, Sagong, Min, Bradvica, Mario, Kim, Mercy Yeeun, Kim, Seungkee, Sadda, SriniVas R.
• Format: Article
• Language: English
• Subjects: Angiogenesis Inhibitors - therapeutic use; Anti-vascular endothelial growth factor; Anti-VEGF; Biologic; Biosimilar; Biosimilar Pharmaceuticals - therapeutic use; Choroidal neovascularization; Diabetic macular edema; Diabetic retinopathy; Eye Diseases - drug therapy; Humans; Intravitreal; Intravitreal Injections; Neovascular age-related macular degeneration; Retinal Diseases - drug therapy; Retinal vein occlusion; Vascular Endothelial Growth Factor A - antagonists & inhibitors
• ISSN: 0039-6257; 1879-3304
• DOI: 10.1016/j.survophthal.2024.03.009

The development of intravitreally injected biologic medicines (biologics) acting against vascular endothelial growth factor (VEGF) substantially improved the clinical outcomes of patients with common VEGF-driven retinal diseases. The relatively high cost of branded agents, however, represents a financial burden for most healthcare systems and patients, likely resulting in impaired access to treatment and poorer clinical outcomes for some patients. Biosimilar medicines (biosimilars) are clinically equivalent, potentially economic alternatives to reference products. Biosimilars approved by leading health authorities have been demonstrated to be similar to the reference product in a comprehensive comparability exercise, generating the totality of evidence necessary to support analytical, pre-clinical, and clinical biosimilarity. Anti-VEGF biosimilars have been entering the field of ophthalmology in the US since 2022. We review regulatory and scientific concepts of biosimilars, the biosimilar development landscape in ophthalmology, with a specific focus on anti-VEGF biosimilars, and discuss opportunities and challenges facing the uptake of biosimilars. •Biologics against VEGF are crucial for the treatment of many retinal diseases.•Ophthalmic anti-VEGF reference biologics typically impose high financial burden.•Approved anti-VEGF biosimilars are clinically equivalent to reference products.•Biosimilars can bring substantial benefits to patients and healthcare systems by reducing cost.•Realization of biosimilar benefits depend, in part, on their successful uptake.