On 27 May 2025, Sandoz’s Afqlir® and Enzeevu®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept 2mg), were approved by Australia’s Therapeutic Good’s Administration (TGA) across 4 products:
- Afqlir® – 40 mg/mL solution for intravitreal injection pre-filled syringe (445959) and vial with needle (445960); and
- Enzeevu® – 40 mg/mL solution for intravitreal injection pre-filled syringe (445957) and vial with needle (445958).
All products are approved for the same indications as the reference products, including nAMD, visual impairment due to macular oedema secondary to central retinal vein occlusion; visual impairment due to macular oedema secondary to branch retinal vein occlusion; diabetic macular oedema; and visual impairment due to myopic choroidal neovascularisation.
This approval makes Sandoz the second sponsor to have aflibercept biosimilars approved in Australia. Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV). Sandoz’s aflibercept biosimilars will be the first to be considered for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC) at its July 2025 meeting, indicating that Sandoz may well be the first to launch in Australia.