As previously reported, on 17 May 2024, a temporary 14 day restraining order was granted preventing Biocon from launching its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron. The purpose of the temporary order was to maintain the status quo until preliminary injunction motions were heard.
On 30 May 2024, the temporary restraining order was extended for a further 14 days to allow additional time for the adjudication of the preliminary injunction motions. Preliminary injunction motions are pending against each of Biocon, Celltrion, Formycon and Samsung Bioepis in respect of alleged infringement of US Patent No. 11,084,865 (ophthalmic formulations of a VEGF antagonist).