EMA — authorised 13 November 2024
- Application: EMEA/H/C/006056
- Marketing authorisation holder: Samsung Bioepis NL B.V.
- Local brand name: Opuviz
- Indication: Opuviz is indicated for adults for the treatment of: neovascular (wet) age-related macular degeneration (AMD) visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) visual impairment due to diabetic macular oedema (DME) visual impairment due to myopic choroidal neovascularisation (myopic CNV)
- Pathway: biosimilar
- Status: approved
On 13 November 2024, the European Medicines Agency (EMA) granted marketing authorisation to Samsung Bioepis NL B.V. for OPUVIZ, a biosimilar treatment. OPUVIZ is indicated for adults with neovascular (wet) age-related macular degeneration (AMD), macular oedema secondary to retinal vein occlusion, diabetic macular oedema, and myopic choroidal neovascularisation. This approval allows OPUVIZ to be used as an alternative treatment option for patients with these eye conditions in the European Union.