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.
Regeneron Blockade Leaves Biocon Facing 2027 Wait On US Eylea Biosimilar
Four Other Firms Also Facing Up To Injunctive Relief Ahead Of Infringement Trial
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.
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