🇪🇺 BYOOVIZ in European Union

EMA authorised BYOOVIZ on 18 August 2021

Marketing authorisation

EMA — authorised 18 August 2021

  • Application: EMEA/H/C/005545
  • Marketing authorisation holder: Samsung Bioepis NL B.V.
  • Local brand name: Byooviz
  • Indication: Byooviz is indicated in adults for: The treatment of neovascular (wet) age-related macular degeneration (AMD) The treatment of visual impairment due to diabetic macular oedema (DME) The treatment of proliferative diabetic retinopathy (PDR) The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) The treatment of visual impairment due to choroidal neovascularisation (CNV)
  • Pathway: biosimilar
  • Status: approved

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BYOOVIZ in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Metabolic approved in European Union

Frequently asked questions

Is BYOOVIZ approved in European Union?

Yes. EMA authorised it on 18 August 2021.

Who is the marketing authorisation holder for BYOOVIZ in European Union?

Samsung Bioepis NL B.V. holds the EU marketing authorisation.