On 9 October 2025, New Zealand’s Medsafe approved Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), in vial and pre-filled syringe presentations, making Afqlir® the first aflibercept biosimilar approved in New Zealand.
Sandoz’s aflibercept biosimilars have received approval in a number of jurisdictions, including the US (August 2024, as Enzeevu®), the EU (November 2024, as Afqlir®), and Australia (May 2025, as Afqlir® and Enzeevu®). Afqlir® and Enzeevu® were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS), 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 6 November 2025.