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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.
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Disclosure
None of the authors have a direct financial interest in this manuscript, though the authors below have the following financial disclosures regarding their relationships with many of the companies whose products are discussed here or alternatively with competitors of companies whose products are mentioned here:
Baruch D Kuppermann: Clinical Research – Alcon, Alimera, Allegro, Allergan, Apellis, Clearside, Genen-tech, GSK, Novartis, Regeneron, ThromboGenics; Consultant – Aerpio, Alcon, Alimera, Allegro, Allergan, Ampio, Catalyst, Cell Care, Dose, Genentech, Novartis, Ophthotech, Regeneron.
Francesco Bandello: Clinical Research – Allergan, Bayer, Boehringer Ingelheim, Hoffman La Roche, Novartis, NTC Pharma, Sifi, Sooft, ThromboGenics, Zeiss.
Dr Anat Lowenstein acts as a consultant/advisor for the following companies: Allergan, Bayer, Beyeonics, ForSight Labs, Notal Vision, Novartis, Alcon, Almira.
Dr Ashish Sharma acts as aconsultant/advisor for the following companies: Allergan, Bayer, Novartis, Intas.
The authors report no other conflicts of interest in this work.