Sandoz Challenges Amgen in Antitrust Lawsuit to Launch Enbrel Biosimilar in the U.S.

Sandoz's Allegations:
Sandoz has filed an antitrust lawsuit against Amgen in the U.S. District Court for the Eastern District of Virginia. The suit accuses Amgen of using its patents to unlawfully block the introduction of biosimilar competition for Enbrel (etanercept), prolonging its market monopoly2 7.

Biosimilar Background:
Erelzi (etanercept-szzs), the Sandoz biosimilar to Enbrel, received FDA approval in 2016 but has yet to launch in the U.S. due to ongoing patent barriers. The drug has been on the market in Europe since 2017, where it significantly reduced prices and gained market share2 3 7.

Amgen’s Alleged Practices:
Sandoz claims Amgen created a "patent thicket," acquiring and leveraging patents to prevent biosimilars like Erelzi from entering the U.S. market. The lawsuit also alleges Amgen shielded its market position through patent acquisitions from competitors such as Roche2 4 5.

Market Impact:
In the U.S., Enbrel generated $3.3 billion in revenue in 2024. Sandoz asserts that Amgen's practices have cost patients and the healthcare system by delaying access to more affordable treatment options3 5 7.

Antitrust Remedies Sought:
Sandoz is pursuing an injunction to allow the immediate launch of Erelzi in the U.S. and seeking treble damages under antitrust law, which could triple the monetary award if Sandoz prevails2 3.

Market Effects in Europe:
Following the introduction of biosimilars in Europe, competition drove Enbrel's price down by up to 50%, with biosimilars capturing 40% of the market within a year of launch2 7.

Broader Context:
The case underscores ongoing challenges in bringing biosimilars to the U.S. market, despite FDA approval pathways for such alternatives. Patent strategies, such as the ones Amgen is accused of employing, have delayed biosimilar competition significantly for several blockbuster medicines like Enbrel and Humira2 9.

This legal battle highlights antitrust and patent-related tensions in the pharmaceutical industry as it pertains to market monopolies and access to cost-effective biosimilar treatments.