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US Court Grants Preliminary Injunctions Preventing Launch of Samsung Bioepis & Formycon Aflibercept Biosimilars

Jun 21, 2024

On 14 and 21 June, respectively, the United States District Court for the Northern District of West Virginia granted Regeneron’s motions for preliminary injunctions against Samsung Bioepis and Formcyon (unpublished to date), preventing them from launching their US biosimilars to Regeneron’s Eylea® (aflibercept).  The orders were made in the BPCIA litigation brought by Regeneron against each of Samsung Bioepis, Formycon, Biocon, Celltrion and Amgen. The order against Samsung Bioepis was published on 24 June 2024, while that against Formycon  remains under seal.   

The preliminary injunction orders are based on the Court’s determination that Samsung Bioepis (Opuviz FDA-approved in May 2024) and Formycon (aBLA for FYB203 accepted by FDA in August 2023) infringed Regeneron’s US patent 11,084,864 (ophthalmic formulations of a VEGF antagonist).   

Both Samsung Bioepis and Formycon lodged appeals from the preliminary injunction orders (on 14 June 2024 and 25 June 2024, respectively).  On 19 June 2024, Samsung Bioepis also filed an Emergency Motion to stay the preliminary injunction pending the appeal. 

This comes after the Court granted Regeneron’s permanent injunction motion on 11 June 2024 (order published on 21 June 2024), preventing Biocon from launching its Yesafili (FDA approved in May 2024) in the US without a licence.   Biocon filed a Notice of Appeal on 21 June 2024.  Preliminary injunction motions remain pending against Celltrion (aBLA for CT-P42 submitted to FDA in June 2023) and Amgen (aBLA for ABP 938 accepted by FDA in October 2023).