On 9 October 2025, The Hague District Court published its decision in legal proceedings between Samsung Bioepis and Regeneron in relation to Regeneron’s Dutch equivalents of European patents EP 2 364 691 and EP 1 183 353, covering formulations of aflibercept. The Court found that the patents were valid and that claim 6 of the ‘691 Patent (an independent claim to a specific lyophilizable formulation of a VEGF antagonist wherein the formulation can be reconstituted so it is suitable for intravitreal administration) was infringed by Samsung Bioepis’ Opuviz™. As a result, the Court granted an injunction preventing Samsung Bioepis from infringing that claim in the Netherlands. The Court denied Regeneron’s request for a cross-border injunction.
The decision of the Dutch Court follows recent decisions in Germany and the UK in relation to Regeneron’s aflibercept patents. In September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction preventing Formycon from launching its aflibercept biosimilar (FYB203) based on a finding of infringement by equivalence of the ‘691 patent. In comparison, in the UK, the High Court determined that Formycon/Klinge’s and Samsung Bioepis’ aflibercept biosimilars did not infringe either the ‘691 patent or Regeneron’s EP (UK) 2 944 306 and that the ‘306 patent was invalid.
Samsung Bioepis’ Opuviz™ (SB15) was the third aflibercept biosimilar approved in Europe in November 2024. Samsung Bioepis and Biogen entered into a commercialisation agreement for Opuviz™ (SB15) in November 2019 for US, Canada, Europe, Japan and Australia. No aflibercept biosimilars have launched in Europe to date.