ARTICLE
14 October 2024

Aflibercept Biosimilar Updates In Europe

GP
Goodwin Procter LLP

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On September 19, 2024, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz's aflibercept biosimilar AFQLIR.
European Union Food, Drugs, Healthcare, Life Sciences

On September 19, 2024, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz's aflibercept biosimilar AFQLIR. On September 20, 2024, Samsung and Biogen announced that the CHMP also adopted a positive opinion for their aflibercept biosimilar OPUVIZ. AFQLIR and OPUVIZ have been recommended for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

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