Biosimilars in ophthalmology: “Is there a big change on the horizon?”

Abstract

Ashish Sharma,1 Prahalad Reddy,1 Baruch D Kuppermann,2 Bandello Francesco,3 Anat Lowenstein41Department of Vitreoretina, Lotus Eye Hospital and Institute, Coimbatore, Tamil Nadu, India; 2Department of Ophthalmology, Gavin Herbert Eye Institute, University of California, Irvine, CA, USA; 3Department of Ophthalmology, Scientific Institute San Raffaele, University Vita-Salute, Milano, Italy; 4Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel Abstract: Retinal disease management has witnessed remarkable advances in posterior segment pharmacotherapy with the development of anti-VEGF molecules such as Lucentis® (ranibizumab), Eylea® (aflibercept), and off-label bevacizumab (Avastin). The US patents for ranibizumab and aflibercept will expire in 2020 (though Regeneron has indicated that it might attempt to extend its US patent to June 2023 with additional patent claims), and their European patents will expire in 2022 and 2025. Aflibercept comes off patent in 2022 in People’s Republic of China and Japan. As soon as each patent expires, biosimilar molecules could potentially come in the mainstream clinical practice as a more cost-efficient choice in the form of generic biosimilars. It is difficult to predict how significant this shift would be in terms of more cost-effective clinical management and how it will impact the care in developed and developing world. It is important for clinicians to have a clear understanding about ophthalmic biosimilars before the industry brings these molecules to the mainstream clinical use globally.Keywords: biosimilar, Razumab®, Lucentis®, Eylea®, ophthalmolog