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Efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration (COLUMBUS-AMD)

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Trial Profile

Efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration (COLUMBUS-AMD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2022

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At a glance

  • Drugs Ranibizumab (Primary)
  • Indications Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms COLUMBUS-AMD
  • Sponsors Bioeq

Most Recent Events

  • 29 Aug 2022 According to Polpharma Biologics media release, the European Commission has granted marketing authorization to Ranivisio ,a biosimilar to Lucentis, for the treatment for several serious retinal diseases in the EU, EC approval follows positive opinion issued in Jun 2022 by the CHMP of the EMA and is applicable to all 27 EU member states plus Iceland, Norway and Liechtenstein; EU-approval is based on the totality of evidence including analytical, nonclinical, clinical and manufacturing data
  • 03 Aug 2022 According to a Food and Drug Administration media release, the U.S. Food and Drug Administration ("FDA") has approved CIMERLI™ (ranibizumab-eqrn) for the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema following Retinal Vein Occlusion (RVO) and Myopic Choroidal Neovascularization (mCNV).
  • 02 Aug 2022 According to a Food and Drug Administration media release, the USFDA has approved CIMERLI as a biosimilar product interchangeable with Lucentis for all five indications, with 12 months of interchangeability exclusivity based on this study.

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