Sandoz Sues Amgen in U.S. Over Alleged Monopoly Tactics on Arthritis Drug Enbrel

Swiss pharmaceutical company Sandoz has filed an antitrust lawsuit in the United States against biotech giant Amgen, accusing it of unfairly blocking competition for its top-selling arthritis medication, Enbrel (etanercept).

Sandoz claims that although its biosimilar version of the drug, Erelzi, was approved by the U.S. Food and Drug Administration (FDA) back in 2016, it has been unable to enter the U.S. market. The company alleges that Amgen created an extensive “patent thicket” — a complex web of patents — to extend Enbrel’s market exclusivity through 2029 and prevent cheaper alternatives from reaching patients.

In the lawsuit, Sandoz is seeking an injunction to break through these legal barriers, as well as monetary damages. It argues that Amgen’s tactics have resulted in billions of dollars in profits while denying patients and health insurers access to more affordable treatment options.

Enbrel, first approved in 1998, is widely used to treat conditions such as rheumatoid arthritis and generated about $3.3 billion in U.S. revenue in 2024 alone.

This legal move follows several previous court rulings that upheld Amgen’s patents. In 2020, a U.S. appeals court sided with Amgen, and the Supreme Court later declined to review the case in 2021.

Amgen has yet to publicly respond to the latest legal challenge from Sandoz.