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

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 fusion protein aflibercept, does not contain a separate buffer component,”...

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