Regeneron Proves Insurmountable As Second FDA Approved Eylea Biosimilar Blocked

Samsung Bioepis Joins Biocon In Feeling Weight Of Injunction; Amgen On Separate Track

 
• By Dean Rudge

Regeneron’s lynchpin US formulation patent for its Eylea 2mg appears to remain a thorn in the side for biosimilar sponsors, as Samsung Bioepis joins Biocon in being blocked from launching its US FDA-approved biosimilar to the near $6bn eye-disease biologic.

• Source: Shutterstock

A US district court has signed off on further injunctive action against the second approved biosimilar to Regeneron’s Eylea (aflibercept) 2mg, days after the first was stopped in its tracks by a similar order.

Samsung Bioepis has filed an immediate appeal to the US Court of Appeals for the Federal Circuit, following an order for a preliminary injunction handed down by US

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