Sandoz Files Antitrust Lawsuit Against Amgen Over Enbrel Market Practices

Swiss pharmaceutical company Sandoz has initiated legal action against U.S. biotech firm Amgen, alleging antitrust violations over efforts to maintain market dominance for its rheumatoid arthritis drug, Enbrel. The lawsuit, filed in a federal court in Norfolk, Virginia, contends that Amgen unlawfully acquired and used patents to suppress competition from lower-cost biosimilars, including Sandoz’s own version, Erelzi.

According to Reuters, Sandoz claims Amgen has built a “thicket of patents” around Enbrel, effectively barring biosimilar alternatives from entering the U.S. market until at least 2029. The Basel-based drugmaker argues this strategy has led to billions in profits for Amgen, while keeping affordable alternatives out of patients’ reach.

Sandoz’s filing, submitted last Friday, asserts that Amgen’s actions violate U.S. federal antitrust laws by unfairly blocking access to biosimilars approved by the U.S. Food and Drug Administration. Erelzi, Sandoz’s etanercept biosimilar, received FDA approval in 2016—the same year it launched the drug in Europe—but it has yet to reach American patients due to the ongoing patent dispute.

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Per Reuters, the lawsuit claims Sandoz is losing “millions of dollars in sales each month” while its product remains off the U.S. market. Enbrel, which is used to treat inflammatory conditions such as rheumatoid arthritis and psoriatic arthritis, generated $3.3 billion in U.S. revenue in 2024 alone, according to Sandoz.

In addition to seeking damages, Sandoz is asking the court for an injunction to prevent Amgen from continuing to use its patent portfolio to delay the launch of Erelzi and other biosimilars.

Amgen has not yet responded publicly to the allegations and did not immediately return a request for comment, Reuters noted.

Source: Reuters