On 5 August 2025, Actor Pharmaceuticals filed legal proceedings against Regeneron and Bayer in the Australian Federal Court. While the details of the proceedings have not yet been published, it is expected that the proceedings are likely to relate to one or more Australian patents regarding Regeneron/Bayer’s Eylea® (aflibercept). The first case management hearing in the proceeding is listed for 8 September 2025.
If the litigation commenced by Actor does relate to aflibercept, it will not be the first Australian aflibercept litigation. On 4 June 2025, Regeneron and Bayer filed proceedings in the Federal Court against Sandoz alleging infringement of Regeneron’s AU2012205599 relating to methods of treatment for angiogenic eye disorders. Regeneron is seeking both an interlocutory injunction and final relief, with the hearing of the interlocutory injunction scheduled for 14 August 2025. Regeneron/Bayer have also filed an application for preliminary discovery in relation to a second of Regeneron’s Australian aflibercept patents, scheduled for hearing on 27 August 2025.
Actor does not currently have any aflibercept biosimilars registered in its name on the ARTG. Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV). Sandoz’s Afqlir® and Enzeevu® were approved by the TGA on 27 May 2025 and were the first to be considered for reimbursement by the Pharmaceutical Benefits Advisory Committee (PBAC) at its July 2025 meeting.