On 17 September 2025, Regeneron filed an application for leave to appeal the decision of Justice Rofe of the Federal Court of Australia refusing to award Regeneron/Bayer a preliminary injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept). The hearing is scheduled for 29 October 2025 before Justices Beach, Burley and Moshinsky.
Regeneron/Bayer commenced the proceedings against Sandoz on 4 June 2025 alleging infringement of Regeneron’s patent no. AU2012205599 relating to methods of treatment for angiogenic eye disorders. Regeneron/Bayer sought both an interlocutory injunction and final relief, and Sandoz cross-claimed for invalidity of the patent. On 3 September 2025, the Federal Court of Australia refused to award Regeneron/Bayer an interlocutory injunction preventing Sandoz from launching its aflibercept biosimilar in Australia.
There is no automatic right to appeal from an interlocutory decision of the Federal Court of Australia and Regeneron/Bayer must obtain leave before the Full Court will hear the appeal. Often the leave application and, if leave is granted, the substantive appeal, are heard at the same time.
Sandoz’s aflibercept biosimilars, Afqlir® and Enzeevu®, were approved by the TGA on 27 May 2025 and were the first aflibercept biosimilars to be considered (and now recommended) for reimbursement, with PBS listing to commence from 1 December 2025. Sandoz indicated during the court proceeding that it does not intend to launch Enzeevu® in 2025.
Actor Pharmaceuticals, which does not yet have any aflibercept biosimilar approved in Australia, filed legal 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.
Regeneron/Bayer are separately seeking preliminary discovery from Sandoz regarding a further Regeneron aflibercept patent, AU2020397865. That matter is scheduled for hearing on 6 November 2025.