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Biosimilar ranibizumab in India- overview of phase 3 clinical trial designs

Eye (2024)Cite this article

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India was the first country in the world to approve ranibizumab biosimilar. The Drug Controller General of India (DCGI) approved Razumab (Intas Pharmaceuticals Limited, Ahmedabad, India) in 2015 as the first biosimilar ranibizumab [1]. The innovator ranibizumab molecule (Lucentis, Genentech, USA) patent expired in June 2020 (USA) and July 2022 (EU) [2]. This has led to a flurry of new drug applications and approval of biosimilar ranibizumab especially in India. At present India has the maximum number of approved ranibizumab biosimilars. India has eight ranibizumab biosimilar products manufactured by four manufacturing facilities. DCGI has approved these molecules based on the pharmacoequivalence data and brief phase 3 clinical trial data. This manuscript aims to provide an overview of the trials on anti-VEGF biosimilars in India.

Razumab received approval for all indications for the reference drug, ranibizumab. This includes neovascular age-related macular degeneration (n-AMD), diabetic macular oedema (DMO), retinal vein occlusion (RVO), myopic choroidal neovascular membrane (m-CNVM), and proliferative diabetic retinopathy (PDR). Furthermore, it has also been approved for the retinopathy of prematurity (ROP). The first approval was obtained in February 2015.

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References

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Acknowledgements

Dr Kuppermann 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. Madhavi Netralaya, Ara, Bihar, India

    Nilesh Kumar

  3. Sankara eye Hospital, Coimbatore, TN, India

    Nikulaa Parachuri

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

    Francesco Bandello

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

    Anat Loewenstein

  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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  2. Nilesh Kumar
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  4. Francesco Bandello
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  5. Anat Loewenstein
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  6. Baruch D. Kuppermann
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Contributions

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

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Correspondence to Ashish Sharma.

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Competing interests

Dr Ashish Sharma: CONSULTANT: for Novartis, Allergan, Bayer and Intas. Dr Francesco Bandello: CONSULTANT: Allergan, Bayer, Boehringer- Ingelheim, FidiaSooft, Hofmann La Roche, Novartis, NTC Pharma, Sifi, Thrombogenics, Zeiss. Dr Anat Loewenstein 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. Dr Baruch D Kuppermann: CLINICAL RESEARCH: Apellis, Genentech Inc, Boehringer Ingelheim, EyePoint, Ionis, IVERIC Bio, Novartis Pharmaceuticals, Regeneron Pharmaceuticals Inc, RegenXBio; CONSULTANT: Aviceda, Allegro Ophthalmics, Allergan/AbbVie, Bausch+Lomb, Boehringer Ingelheim, Clearside, Coherus, EyeBio, Eyedaptic, EyePoint, Genentech Inc, Glaukos Corporation, InflammX Therapeutics, IVERIC Bio, jCyte, Mobius, Neurotech Pharmaceuticals, Novartis Pharmaceuticals, Ocular Therapeutix, Outlook Therapeutics, Regeneron Pharmaceuticals Inc, ReVana Therapeutics, Ripple Therapeutics, Stealth Biotherapeutics, TechImmune, Theravance Biopharma, Visgenx. Dr Nilesh Kumar: None. Dr Nikulaa Parachuri: None.

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Sharma, A., Kumar, N., Parachuri, N. et al. Biosimilar ranibizumab in India- overview of phase 3 clinical trial designs. Eye (2024). https://doi.org/10.1038/s41433-024-03001-8

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  • DOI: https://doi.org/10.1038/s41433-024-03001-8

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