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Ranibizumab biosimilar - Xbrane

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Drug Profile

Ranibizumab biosimilar - Xbrane

Alternative Names: Lucentis biosimilar - Xbrane; Ximluci; Xlucane

Latest Information Update: 23 Apr 2024

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At a glance

  • Originator Xbrane
  • 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
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Choroidal neovascularisation; Diabetic macular oedema; Diabetic retinopathy; Retinal vein occlusion; Wet age-related macular degeneration
  • Preregistration Degenerative myopia; Retinal oedema

Most Recent Events

  • 21 Apr 2024 Xbrane receives complete response letter from the US FDA for Ranibizumab biosimilar in Choroidal neovascularization, Degenerative myopia, Diabetic macular oedema, Retinal oedema, Diabetic retinopathy, Retinal vein occlusion, and Wet age-related macular degeneration
  • 24 Jul 2023 Xbrane and STADA Arzneimittel terminates its commercialisation agreement with Bausch & Lomb for ranibizumab biosimilar in North America
  • 26 Jun 2023 The US FDA sets BsUFA date of 21/04/2024 for ranibizumab biosimilar for Wet age-related macular degeneration
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