On 31 March 2025, Celltrion’s Eydenzelt® (CT-P42), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved by Australia’s Therapeutic Good’s Administration (TGA) as follows:
- 40 mg/mL solution for intravitreal injection pre-filled syringe (431931); and
- 40 mg/mL solution for intravitreal injection vial with needle (431932).
Eydenzelt® is indicated for the treatment of visual impairment due to myopic choroidal neovascularisation (myopic CNV).
Eydenzelt® is the first aflibercept biosimilar approved in Australia. It has recently been approved in Europe (February 2025) for the treatment of multiple retinal disorders, including nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV). Celltrion filed a US NDA in June 2023 for Eydenzelt® and received Korean approval in May 2024.