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Aflibercept biosimilars – update on the development progress

Eye volume 38, pages 824–825 (2024)Cite this article

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In the past 2 years, there have been multiple approvals of ranibizumab biosimilars across the globe. There are some that are approved by the local regulatory authority of a country; for example, the Drug Controller General of India has approved two ranibizumab biosimilars (Ranieyes, by Lupin Ltd and Ranizurel by Reliance Life Sciences) in India [1]. The Ministry of Food & Drug Safety of South Korea approved CKD-701 by Chong Kun Dang Pharmaceutical Corp [2]. Furthermore, the Pharmaceuticals and Medical Device Agency of Japan has approved Ranibizumab BS1 by Senju Pharma [1]. Apart from these three ranibizumab biosimilar molecules, other drugs such as Byooviz by Samsung Bioepis South Korea, Cimerli (USA)/Ongavia (UK)/Ranivisio (Europe) from Coherus, USA received approval from both United States Food and Drug Administration (US-FDA) and the European Medical Agency (EMA) [1]. Ximluci by STADA, Germany, has received approval from the EMA and the Biologics License Application (BLA) has been filed for US-FDA [3].

The approval of ranibizumab biosimilars was a welcome change to improve the access of ranibizumab to many patients across the globe by making it cost-effective. However, over time Eylea (Aflibercept, Regeneron, USA) has become the most common anti-vascular endothelial growth factor (anti-VEGF) used across the globe due to its better efficacy [4]. Recently, the first Eylea biosimilar (YESAFILI by Biocon Pharmaceuticals, India/previously known as MYL1701P from Momenta Pharmaceuticals/Viatris) received European Commission approval for market authorization in the European Union [5]. Probably this is the beginning of a larger change that the retina speciality will see in upcoming years in terms of access to the aflibercept at an affordable price. Biocon has not yet revealed the price point but based on the experience from ranibizumab biosimilars, it could be anywhere between 25 and 50% less than the originator aflibercept (Eylea).

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References

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Authors and Affiliations

  1. Lotus Eye Hospital and Institute, Avinashi Road, Coimbatore, TN, India

    Ashish Sharma

  2. Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel

    Anat Loewenstein

  3. Madhavi Netralaya, Ara, Bihar, India

    Nilesh Kumar

  4. Department of Vitreoretina, Sankara Eye Hospital, Coimbatore, TN, India

    Nikulaa Parachuri

  5. University Vita-Salute, Scientific Institute San Raffaele, Milano, Italy

    Francesco Bandello

  6. Gavin Herbert Eye Institute, University of California, Irvine, Irvine, CA, USA

    Baruch D. Kuppermann

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  1. Ashish Sharma
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  5. Francesco Bandello
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Contributions

AS: conception, analysis, drafting, integrity check, final approval. AL, NP, NK, BDK: drafting, revision, analysis, integrity check.

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Correspondence to Ashish Sharma.

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Competing interests

AS—consultant: Novartis, Allergan, Bayer, Lupin and Intas and speaker fee: Biogen. AL—consultant: Allergan, Novartis, Roche, Notal Vision, ForSight Labs, Beyeonics, Bayer Health Care. NP—None. NK—None. FB—consultant: Allergan, Bayer, Boehringer Ingelheim, FidiaSooft, Hofmann La Roche, Novartis, NTC Pharma, Sifi, Thrombogenics, Zeiss. BDK—clinical research: Alcon, Alimera, Allegro, Allergan, Apellis, Clearside, Genentech, GSK, Ionis, jCyte, Novartis, Regeneron, ThromboGenics and consultant: Alimera, Allegro, Allergan, Cell Care, Dose, Eyedaptic, Galimedix, Genentech, Glaukos, Interface Biologics, jCyte, Novartis, Ophthotech, Regeneron, Revana, Theravance Biopharma.

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Sharma, A., Loewenstein, A., Kumar, N. et al. Aflibercept biosimilars – update on the development progress. Eye 38, 824–825 (2024). https://doi.org/10.1038/s41433-023-02813-4

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