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Aflibercept 2 mg biosimilars—will they lead the Anti-VEGF biosimilar world globally

Eye volume 39, pages 1026–1027 (2025)Cite this article

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Ranibizumab biosimilars, equivalents of the originator drug Lucentis (Genentech, USA), have been increasingly adopted worldwide since the introduction of the first biosimilar, Razumab (Intas Pharmaceuticals, Ahmedabad, India), in 2015 [1]. Today, these biosimilars are widely available for managing retinal diseases globally. Several ranibizumab biosimilars have secured approval from prominent regulatory agencies, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Additionally, local regulatory authorities in countries such as India, South Korea, the United Kingdom, and Japan have granted approvals, facilitating successful domestic use [2]. The growing use of ranibizumab biosimilars has heightened awareness among retinal physicians regarding the nuances of these molecules. Initially, surveys indicated a negative perception of biosimilars; however, over time, their adoption has increased worldwide. Several organizations, including the FDA, EMA, and International Federation on Aging (IFA), have launched educational initiatives to promote understanding of biosimilars in treating retinal diseases [3, 4]. Our group, the International Retina Biosimilar Study Group (Inyter BIOS Group), has taken the lead in publishing real-world data on biosimilar ranibizumab from various global regions [5]. Additionally, educational courses on biosimilar understanding are being integrated into retinal expert meetings. Regulatory agencies, such as the US FDA and EMA, have made significant contributions to this effort. Through collaborative endeavours, the adoption of ranibizumab biosimilars has improved, becoming the first-line therapy in step therapy protocols in many countries. Furthermore, biosimilar ranibizumab is replacing off-label bevacizumab usage in several regions. However, in some developed countries, such as the United States, the usage of ranibizumab and its biosimilars remains limited.

Aflibercept 2 mg (Eylea, Regeneron, USA) has been the preferred treatment option in many regions, including the US and Europe. Recently, the US FDA approved five aflibercept 2 mg biosimilars. However, aside from aflibercept-ayyh (Pavblu, Amgen, USA), other companies have yet to overcome proprietary hurdles. In other countries, aflibercept 2 mg biosimilars have received approval and are being used clinically. Examples include Afilivu (Samsung Bioepis/Samil Pharmaceuticals) in South Korea and Tyalia (CinnaGen) in Iran [6, 7]. Apart from several aflibercept 2 mg biosimilar molecules that have completed phase 3 trials, many other companies have ongoing Phase 3 trials. This indicates a promising pipeline of aflibercept biosimilars for future treatment options.

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References

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Acknowledgements

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

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Authors and Affiliations

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

    Ashish Sharma

  2. Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea

    Se Joon Woo

  3. Institute of Vision Research, Department of Ophthalmology, Severance Eye Hospital, Yonsei University College of Medicine, Seoul, Korea

    Christopher Seungkyu Lee

  4. Madhavi Netralaya, Ara, Bihar, India

    Nilesh Kumar

  5. Aster Hospital, Sharjah, UAE

    Nikulaa Parachuri

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

    Francesco Bandello

  7. Division of Ophthalmology, Tel Aviv Medical, Tel Aviv University, Tel Aviv, Israel

    Anat Loewenstein

  8. 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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  6. Francesco Bandello
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  8. Baruch D. Kuppermann
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Contributions

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

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Correspondence to Ashish Sharma.

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Competing interests

AS: CONSULTANT: for Novartis, Allergan, Bayer and Intas. SJW: received consulting fees from Samsung Bioepis, Curacle, Novelty Nobility, Pharmabcine, Sometech, Samil, Allergan, Janssen; lecture fees from Bayer, Navartis, Allergan/Abbvie, Santen, Samil; grants from Samsung Bioepis, Alcon, Alteogen, Curacle, Kyowa Kirin, Novelty Nobility, Novartis, Pharmabcine, Roche; owns equity of RetiMark and Panolos Bioscience. CSL: CLINICAL TRIALS: Bayer, Roche, Novartis, Pharmabcin, Alteogen, Kyowa Kirin; CONSULTING FEES: Eyegene, Allergan/Abbvie, Santen, Curacle, Pharmabcin, Samil, Chong Kun Dang; LECTURE FEES: Bayer, Novartis, Allergan/Abbvie, Roche, Santen, Samil, Kukje. NK: None. NP: None. Dr Francesco Bandello: CONSULTANT: Allergan, Bayer, Boehringer- Ingelheim, FidiaSooft, Hofmann La Roche, Novartis, NTC Pharma, Sifi, Thrombogenics, Zeiss. AL reports other from Allergan, other from Novartis, other from Roche, other from Notal Vision, other from Forsightslabs, other from Beyeonics, other from Bayer Health Care. BDK: CLINICAL RESEARCH: Adverum, Alimera, Allegro, Allergan, Apellis, Astellas, Boehringer Ingelheim, Clearside, EyePoint, 4DMT, Genentech, GSK, Ionis, IvericBio, jCyte, Novartis, Regeneron CONSULTANT: AbbVie, Adverum, Alimera, Alkeus, Allegro,, Apellis, Astellas, Eyebio, Eyedaptic, EyePoint, ForVision, Galimedix, Genentech, Glaukos, Inflammx, Interface Biologics/Ripple Therapeutics, jCyte, Novartis, Ocular Therapeutix, Oculis, OphtiMedRx, Outlook Therapeutics, Regeneron, Revana, Theravance Biopharma, VisgenX.

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Sharma, A., Woo, S.J., Lee, C.S. et al. Aflibercept 2 mg biosimilars—will they lead the Anti-VEGF biosimilar world globally. Eye 39, 1026–1027 (2025). https://doi.org/10.1038/s41433-025-03732-2

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