On 18 September 2025, Samsung Bioepis’ Opuviz®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), was approved by Australia’s Therapeutic Goods Administration (TGA) in 2 presentations:
- OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial (456527)
- OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial with needle (456528)
The PI for Opuviz® is not yet available.
With this approval, Samsung Bioepis becomes the third sponsor with an approved aflibercept biosimilar in Australia. Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV), which was followed by Sandoz’s Afqlir® and Enzeevu® on 27 May 2025. Sandoz’s products were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme with listing anticipated on 1 December 2025.
Aflibercept is currently the subject of patent infringement proceedings in Australia. On 8 September 2025, the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer an interlocutory injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®. Regeneron/Bayer filed an application for leave to appeal that decision on 17 September 2025. Regeneron/Bayer are separately seeking preliminary discovery from Sandoz in relation to a second Regeneron aflibercept patent, AU2020397865, which is scheduled for hearing on 6 November 2025.
Actor Pharmaceuticals, which does not yet have an aflibercept biosimilar approved in Australia, filed revocation proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter currently scheduled for 8 October 2025.