Amgen Shares Under Pressure as Sandoz Files Antitrust Suit Over Enbrel Monopoly

Amgen, a prominent player in the biotech sector, is currently navigating a significant legal challenge. On April 14, 2025, Sandoz, a global leader in generics and biosimilars, filed an antitrust lawsuit against Amgen in the United States. The lawsuit alleges that Amgen has engaged in improper practices to maintain and extend its monopoly over its blockbuster drug, Enbrel® (etanercept), in the U.S. market. Sandoz has claimed that Amgen's alleged conduct has obstructed the entry of more cost-effective biosimilars, including Sandoz's own Erelzi® (etanercept-szzs).

Enbrel® has long been a staple in the treatment of various debilitating inflammatory diseases, with FDA approval dating back to 1998. In 2024, Enbrel® generated a substantial $3.3 billion in U.S. revenue, underscoring its dominant market presence. Despite Erelzi® receiving FDA approval in 2016 and launching successfully in Europe, it has yet to penetrate the U.S. market nearly a decade later. This delay has been attributed to Amgen's alleged strategic acquisition and deployment of certain patent rights.

The lawsuit filed by Sandoz emphasizes the impact of such practices on market competition, suggesting it not only restricts market access for more affordable biosimilars but also burdens patients with higher healthcare costs. The ongoing patent protection for Enbrel® is expected to persist until 2029, posing significant barriers for biosimilar competition in the market.

This legal battle between Sandoz and Amgen reflects broader industry concerns regarding fair competition and market dynamics in the pharmaceutical sector. As the case unfolds, it highlights the critical discourse surrounding innovation, patent laws, and accessibility within the healthcare landscape. The outcome of this lawsuit could have far-reaching implications for the introduction and pricing of biosimilars in the U.S. market, potentially influencing future regulatory and competitive strategies in the industry.