Emerging biosimilars for retinal diseases

ABSTRACT

Introduction

Biosimilars for retinal diseases have been a topic of discussion recently due to the approval of two biosimilar ranibizumab by the US FDA and EMA. It is important to understand this emerging field in retina with many other biosimilar anti-VEGF molecules in the final stage of their trials. Hopefully, they will be available for clinical use very soon.

Areas covered

Articles update about the approved biosimilar ranibizumab for retinal diseases and list out ranibizumab and aflibercept biosimilars in the pipeline.

Expert opinion

Approval of biosimilar anti-VEGFs might be able to drive a geographically variable change in the usage of retinal pharmacotherapy based on the local policies of the health system.

KEYWORDS:

• Aflibercept
• Anti-VEGF
• biosimilar
• eylea
• lucentis
• ranibizumab

Article highlights

• Many biosimilar ranibizumab and aflibercept molecules are in the final phase of clinical trials

• Most of the aflibercept molecules are looking for approval in 2026 as Regeneron has multiple patents on Eylea till 2026

• Despite two major biosimilar ranibizumab approvals by the FDA and EMA, a few more ranibizumab biosimilars are in the pipeline for approval.

• Biosimilar anti-VEGFs have the potential for significant cost savings for health systems globally

• Appropriate education and real-world safety data about biosimilar anti-VEGFs can be of great help for physicians to develop trust in these molecules

Acknowledgements

BD Kuppermann acknowledges an unrestricted grant from Research to Prevent Blindness to the Gavin Herbert Eye Institute at the University of California, Irvine.

Author contributions

A Sharma: conception, analysis, drafting, integrity check, final approval. N Parachuri, N Kumar, F Bandello and BD Kuppermann: drafting, revision, analysis, integrity check.

Declaration of interest

A Sharma has acted as a consultant for Novartis, Allergan, Bayer, and Intas. F Bandello has acted as a consultant for Allergan, Bayer, Boehringer-Ingelheim, FidiaSooft, Hofmann La Roche, Novartis, NTC Pharma, Sifi, Thrombogenics, and Zeiss. BD Kuppermann has performed clinical research for Alcon, Alimera, Allegro, Allergan, Apellis, Clearside, Genentech, GSK, Ionis, jCyte, Novartis, Regeneron, and ThromboGenics and has acted as a consultant for Alimera, Allegro, Allergan, Cell Care, Dose, Eyedaptic, Galimedix, Genentech, Glaukos, Interface Biologics, jCyte, Novartis, Ophthotech, Regeneron, Revana, and Theravance Biopharma. N Kumar has acted as a consultant and speaker for Lupin. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This paper was not funded.