Swiss pharmaceutical company Sandoz has filed an antitrust lawsuit against Amgen in the United States, accusing the company of unlawfully maintaining its dominant position in the market for its popular arthritis drug, Enbrel (etanercept).
Sandoz claims that Amgen has blocked competition from more affordable biosimilars, including Sandoz’s own etanercept biosimilar, Erelzi, by misusing patent rights to secure its monopoly. This legal action was taken after Sandoz alleged that Amgen’s strategy of using a “thicket of patents” unfairly extended the patent protection for Enbrel through 2029, which the company argues violates U.S. federal antitrust laws.
The lawsuit, filed in a Norfolk, Virginia, federal court, contends that Amgen’s actions have allowed the company to generate billions in profits while preventing patients and healthcare providers from benefiting from lower-priced alternatives. Sandoz further claims that its biosimilar, Erelzi, has been blocked from entering the U.S. market, resulting in significant financial losses for the company.
In 2024, Enbrel earned $3.3 billion in revenue in the U.S. alone. The drug is widely used to treat inflammatory conditions such as rheumatoid arthritis. Sandoz received approval from the U.S. Food and Drug Administration (FDA) for Erelzi in 2016, the same year the biosimilar was launched in Europe.
Sandoz is seeking an injunction to prevent Amgen from using its patent rights to impede biosimilar competition and allow the company to launch Erelzi without further delay. In addition, Sandoz is pursuing damages for the financial harm caused by Amgen’s actions.
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