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Amgen’s Bufferless Eylea Biosimilar Again Knocks Back Regeneron’s Injunctive Bid

‘A Substantial Question Of Noninfringement,’ US Federal Circuit Finds As It Affirms On Appeal

 
• By Dean Rudge

Amgen’s biosimilar aflibercept formulation is keeping it head and shoulders above other would-be Eylea biosimilar competitors, while continuing to frustrate originator Regeneron’s push to block sales of the product while it battles Amgen over alleged infringement of a key US patent.

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Amgen’s biosimilar to Regeneron’s Eylea (aflibercept) will remain available on the US market while the two companies continue to litigate over a key patent, after the US Court of Appeals for the Federal Circuit affirmed an order denying the originator’s bid for a preliminary injunction.

The Federal Circuit in a 14 March judgment noted that Amgen’s Pavblu (aflibercept-ayyh) formulation, “while contain[ing] a version of the...

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