On 4 June 2025, Regeneron and Bayer filed proceedings against Sandoz in the Australian Federal Court 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.
The first case management hearing in the proceeding was held on 23 June 2025, with Sandoz publicly confirming that it intends to PBS-list and launch Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in Australia from 1 December 2025. Sandoz does not presently intend to exploit its other ARTG-listed aflibercept biosimilar, Enzeevu®, in Australia during 2025.
Sandoz indicated at the case management hearing that it will be filing a cross-claim seeking to invalidate the AU599 patent, including for lack of novelty.
The hearing of Regeneron/Bayer’s interlocutory injunction application is scheduled for 14 August 2025.