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Clinical Ophthalmology Volume 15, 2021 - Issue
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Original Research

Randomised, Double-blind, Comparative Clinical Study of New Ranibizumab Biosimilar in Neovascular (Wet) Age-Related Macular Degeneration

Prasad ApsangikarReliance Life Sciences Pvt. Ltd, Mumbai, IndiaCorrespondence[email protected]
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,
Pravin GhadgeReliance Life Sciences Pvt. Ltd, Mumbai, IndiaView further author information
,
Manoj NaikReliance Life Sciences Pvt. Ltd, Mumbai, IndiaView further author information
,
Santosh NairReliance Life Sciences Pvt. Ltd, Mumbai, IndiaView further author information
&
Ravikiran PayghanReliance Life Sciences Pvt. Ltd, Mumbai, IndiaView further author information
Pages 3087-3095 | Published online: 16 Jul 2021

References

  • Woo SJ, Veith M, Hamouz J, et al. Efficacy and safety of a proposed ranibizumab biosimilar product vs a reference ranibizumab product for patients with neovascular age-related macular degeneration. JAMA Ophthalmol. 2021;139(1):68–76. doi:10.1001/jamaophthalmol.2020.5053
  • Guidelines on similar biologics: regulatory requirements for marketing authorization in India; August 15, 2016.
  • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Guidance for Industry. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); April, 2015.
  • RanizuRel (ranibizumab) Clinical Study Report (Jan 2020). Reliance Life Sciences. Version 2.0.; January, 2020.

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