Amgen’s Formulation of Eylea Biosimilar Saved It From Injunction

Amgen Inc. avoided Regeneron Pharmaceuticals Inc.’s attempt to block its Eylea biosimilar because a federal judge in West Virginia found its version of the blockbuster eye-disease drug—unlike the four Regeneron successfully blocked—lacks a required separate buffer, according to a redacted order.

Regeneron on Sept. 23 immediately appealed Judge Thomas S. Kleeh’s sealed order denying its request for a preliminary injunction against Amgen’s Pavblu, previously called ABP 938.

Kleeh found that the asserted claims of US Patent No. 11,084,865 require that the vascular endothelial growth factor antagonist—aflibercept, Eylea’s active ingredient—and the buffer—an inactive ingredient that stabilizes the drug’s pH level—must be ...