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Regeneron Blockade Leaves Biocon Facing 2027 Wait On US Eylea Biosimilar

Four Other Firms Also Facing Up To Injunctive Relief Ahead Of Infringement Trial

 
• By Dean Rudge

Biocon has been handed a further setback in its attempts to launch a biosimilar to the market-leading Eylea in the US, after a US district court signed off on a permanent injunction against the Indian firm lasting until June 2027. Meanwhile, decisions on motions for preliminary injunctions against several other biosimilar sponsors are imminent.

US flag gavel (Andriy Popov/Alamy Stock Photo)
• Source: Shutterstock (Andriy Popov / Alamy Stock Photo/Alamy Stock Photo)

Despite holding US Food and Drug Administration approval, Biocon looks set to be barred from launching its Yesafili (aflibercept-jbvf) biosimilar to Regeneron’s near $6bn Eylea low-dose 2mg formulation until June 2027 after the originator was granted a permanent injunction.

Judge Thomas Kleeh, presiding over sprawling biosimilar Eylea litigation in the US District Court for the Northern District of West Virginia, has signed an order granting Regeneron’s motion for permanent

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