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Ranibizumab biosimilar - Lupin

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Drug Profile

Ranibizumab biosimilar - Lupin

Alternative Names: LUBT-010; RaniEyes; RanluspecTM

Latest Information Update: 22 Dec 2025

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At a glance

  • Originator Lupin
  • Class Eye disorder therapies; Immunoglobulin fragments; Monoclonal antibodies
  • Mechanism of Action Vascular endothelial growth factor A inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Wet age-related macular degeneration
  • Phase III Age-related macular degeneration

Most Recent Events

  • 22 Dec 2025 Preregistration for Wet age-related macular degeneration (In the elderly, In adults) in European Union (Intravitreous)
  • 17 Dec 2025 The Committee for Medicinal Products for Human Use (CHMP) recommends approval of ranibizumab biosimilar for Wet age-related macular degeneration in European Union
  • 12 Aug 2025 Ranibizumab biosimilar market licensed to Sandoz in the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia

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