Anti-vascular endothelial growth factors (anti-VEGF) agents combat retinal diseases causing blindness. However, high costs and non-adherence pose challenges. Ophthalmic anti-VEGF ranibizumab biosimilars, which have received multiple approvals in South Asia, are helping to reduce healthcare costs and revolutionize ophthalmic treatments.
Anti-VEGF agents have been at the forefront of combating blindness secondary to vascular and exudative diseases of the retina. However, a 2023 study conducted by Sharma A et al. noted that, due to various factors involved in anti-VEGF therapy, the non-adherence rate exceeds 50% at the end of the first year. Long-term compliance with this therapy is significantly hindered by the considerable expense.
Biosimilars, which have similar efficacy and safety to the innovator molecule and share the same protein structure, offer 35%–50% reduction on the cost of therapy. This cost reduction is possible due to the lower research and development costs involved in the production of biosimilars .
South Asian countries such as India, South Korea, and Japan have played a key role in spearheading the research and development of the biosimilar anti-VEGF ranibizumab for retinal diseases. When the Drug Controller General of India granted marketing authorization for a similar biologic of ranibizumab (Razumab, Intas Pharmaceuticals, India) in June 2015, India became the first nation in the world to approve a similar biologic to ranibizumab (Lucentis, Genentech, USA) .
This positioned India as a pioneer in the field of ophthalmic biosimilars and over the next seven years, the nation's retinal specialists gained extensive experience. Finally, in September 2021, the US Food and Drug Administration (FDA) approved the biosimilar candidate ranibizumab-nuna (Byooviz, Samsung Bioepis, South Korea and Biogen, USA) which was developed under the code name of SB-11 . As the patents for ranibizumab expired in the US and the EU in June 2020 and July 2022, respectively, there has been a flurry of approvals. The majority of these approvals, including ranibizumab-nuna, ranibizumab BS-1 (Senju Pharmaceuticals, Japan), ranieyes (Lupin Ltd, India), and ranizurel (by Reliance Life Sciences, India), are in the South Asian region. Despite being licensed by the European Medical Agency and the FDA, ranibizumab-eqrn (Cimerli, Coherus, USA) is not authorized in South Asia .
Based on a recently completed survey by the authors’ team, the International Retina Biosimilar Group (Inter-BIOS) study group, in collaboration with Vitreoretinal Society of India (VRSI), revealed that the majority of retina practices consist of usage of ranibizumab biosimilar. Furthermore, the survey revealed that biosimilar ranibizumab has improved the affordability and access to this therapy (unpublished data). In addition, the survey finds encouraging indicators in terms of enhanced availability and the dominance of ophthalmic biosimilars in South Asia. Therefore, the Inter-BIOS study group hopes to conduct more of these country-specific surveys in the future to understand the changes that biosimilars might bring about globally.
In the same region, the authors highlight other aflibercept biosimilar candidates being evaluated at different levels. Aflibercept is the most widely used anti-VEGF in the West but not in South Asia, thus, this would likely have a greater impact on the South Asian region.
With the approval of more biosimilars, leading to better availability and lower costs for ophthalmic treatments, the authors assert that this would significantly impact the economics of South Asia.
Conflict of interest
Dr Ashish Sharma reported that he is a consultant for Intas Pharmaceuticals, Lupin Ltd, Novartis India, Bayer India. For full details of the authors’ conflict of interest, see the research paper .
Abstracted by Ashish Sharma, MS, MD, Consultant Retina and Head Research, Lotus Eye Hospital and Institute, Coimbatore, TN, India.
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1. Sharma A, Kumar N, Parachuri N, et al. Biosimilars for retinal diseases: an update. Am J Ophthalmol. 2021;224:36-42.
2. Sharma A, Reddy P, Kuppermann BD, et al. Biosimilars in ophthalmology: is there a big change on the horizon? Clin Ophthalmol. 2018;12:2137-43.
3. Biogen. FDA approves Samsung Bioepis and Biogen’s BYOOVIZTM (SB11), LUCENTIS® Biosimilar (ranibizumab-nuna) Biogen [homepage on the Internet]. [cited 2023 Oct 24]. Available from: https://investors.biogen.com/news-releases/news-release-details/fda-approves-samsung-bioepis-and-biogens-byooviztm-sb11
4. Sharma A, Kondo M, Iwahashi C, et al. Approved biosimilar ranibizumab-a global update. Eye (Lond). 2023;37(2):200-2.
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