VIRGINIA — Pharmaceutical company Sandoz has filed a federal lawsuit accusing Amgen of orchestrating an illegal scheme to block biosimilar competition for its blockbuster arthritis drug Enbrel, resulting in inflated prices for American patients and insurers.
The Enbrel biosimilar lawsuit, lodged Friday in the Eastern District of Virginia, claims that Amgen violated antitrust laws by engaging in anti-competitive behavior, including acquiring strategic patents and manipulating licensing agreements to shut out rivals from the etanercept market—Enbrel’s active ingredient.
Decades-Long Monopoly Alleged
Sandoz asserts that Amgen’s anti-competitive conduct dates back to 2002, following its acquisition of Enbrel’s original manufacturer, Immunex. By 2004, Enbrel sales had ballooned to nearly $2 billion annually, making it Amgen’s highest-grossing drug.
Fearing future competition from biosimilars after its patents were set to expire in 2015, Amgen allegedly moved to secure exclusive control over key patent rights from F. Hoffmann-La Roche, the Swiss firm that first sequenced Enbrel’s core receptor technology. Although Roche had licensed these patents non-exclusively, Amgen allegedly transformed that deal into an exclusive arrangement, effectively locking out competitors like Sandoz.
“Amgen chose to scheme,” Sandoz claimed in the suit. “Rather than compete fairly, it pursued a course to extend its monopoly beyond what the law allows.”
