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Samsung Bioepis Relaunches BYOOVIZ® (ranibizumab-nuna) in the United States in Partnership with Harrow

HROW
  • In July 2025, Samsung Bioepis & Harrow formed a partnership to commercialize interchangeable ophthalmology biosimilars BYOOVIZ (ranibizumab-nuna) & OPUVIZ (aflibercept-yszy) in the US.
  • Harrow assumed full commercialization responsibility for BYOOVIZ & OPUVIZ following the return of rights from Biogen to Samsung Bioepis at the end of 2025.
  • Samsung Bioepis retains responsibility for development, regulatory registration, & manufacturing, while Harrow manages commercialization efforts.
  • BYOOVIZ was the first ophthalmology biosimilar to receive FDA approval in September 2021 & was granted interchangeability designation in October 2023.
  • Biogen had previously commercialized BYOOVIZ since June 2022 before returning the rights to Samsung Bioepis.
  • BYOOVIZ is indicated for Neovascular (Wet) AMD, Macular Edema following RVO, & Myopic Choroidal Neovascularization (mCNV).
  • OPUVIZ is indicated for Neovascular (Wet) AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), & Diabetic Retinopathy (DR).
  • Both products are vascular endothelial growth factor (VEGF) inhibitors that serve as interchangeable biosimilars to Lucentis (ranibizumab) & Eylea (aflibercept), respectively.
  • Wet AMD affects approximately 1.2% to 1.3% of US adults aged 65+ with 1.5 million Americans living with late-stage vision-threatening disease.
  • Common adverse reactions for BYOOVIZ include conjunctival hemorrhage, eye pain, vitreous floaters, & increased intraocular pressure (IOP).
  • Common adverse reactions for OPUVIZ include conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, & increased IOP.
  • Both products carry warnings regarding endophthalmitis, retinal detachments, increased IOP, & potential arterial thromboembolic events following intravitreal injection.
  • BYOOVIZ also received approval from the European Commission, UK, & Canada in August 2021, March 2022, & 2021 respectively.