As previously reported, in the context of the ongoing US aflibercept litigation, Regeneron previously filed motions for preliminary injunctions against each of Celltrion, Formycon and Samsung Bioepis. On 21 May 2024, Regeneron withdrew its preliminary injunction motions in respect of all patents other than US Patent No. 11,084,865 (relating to ophthalmic formulations of a VEGF antagonist) “[i]n an effort to streamline the issues in dispute”.
The Court previously determined that Biocon infringed eight claims of Regeneron’s US patent 11,084,865 in a judgment delivered on 27 December 2023 and published on 31 January 2024. Based on that decision, a temporary 14 day restraining order was granted on 17 May 2024, preventing Biocon from manufacturing, using, marketing and selling its Yesafili® (aflibercept) biosimilar in, or importing it into, the US without a licence from Regeneron
This news follows Regeneron’s filing of a second complaint against Celltrion on 17 May and the FDA’s approval on 20 May 2024 of Samsung Bioepis’ Opuviz (aflibercept-yszy) and Biocon’s YesafiliTM (aflibercept-jbvf), the first interchangeable biosimilars to Regeneron’s Eylea® approved in the US.