On 8 September 2025, Justice Rofe of the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer a preliminary injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).
Regeneron and Bayer commenced 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.
The interlocutory injunction application was heard on 14 August 2025 with Justice Rofe announcing her decision on 3 September 2025 and publishing her reasons for judgment on 8 September 2025. Justice Rofe found an “insufficient likelihood of success” that Regeneron/Bayer’s infringement case would succeed at a final hearing and that the balance of convenience did not favour the grant of the interlocutory injunction.
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 while Afqlir® will be launched in Australia in the coming months, it does not intend to launch Enzeevu® in 2025.
Subject to any settlement, the case will now proceed to a hearing for final relief.
Actor Pharmaceuticals, which does not yet have any aflibercept biosimilar approved in Australia, has 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 scheduled for 8 October 2025.
Regeneron/Bayer are separately seeking preliminary discovery from Sandoz in relation to a second Regeneron’s aflibercept patent, AU2020397865, which is scheduled for hearing on 6 November 2025. Regeneron/Bayer have indicated that they may wish to seek an interlocutory injunction in relation to that patent, depending on the outcome of the preliminary discovery application.
On 9 September 2025, Sandoz announced that it settled all US patent disputes between it and Regeneron relating to Sandoz’s Enzeevu®. Under the terms of the US settlement, Sandoz is permitted to launch its biosimilar aflibercept in the US in Q4 2026, or earlier in certain undisclosed circumstances.