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A Three-Year Wait? Biocon Set To Weigh US Eylea Judgment

Regulatory Exclusivity For Blockbuster Biologic Expires In Four Months

 
• By Dean Rudge

A bench trial closely watched since June last year has delivered a verdict – although it’s not a completely happy picture for US Eylea (aflibercept) biosimilar hopeful Biocon.

judge gavel
• Source: Shutterstock

Biosimilar competition to Regeneron’s blockbuster eye disease biologic Eylea (aflibercept) 2mg could be kept from the US market for a further three years following a mixed ruling for Biocon in closely watched litigation.

Following a bench trial, US District Court for the Northern District of West Virginia judge Thomas Kleeh ruled that Regeneron demonstrated “by a preponderance of the evidence” that the Indian firm’s proposed biosimilar infringes multiple claims of the

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