Sandoz Files Antitrust Lawsuit Against Amgen for Delaying Entry of Etanercept Biosimilar
On April 14, 2025, Sandoz, a leading global pharmaceutical company specializing in generic and biosimilar medicines, announced the filing of an antitrust lawsuit against Amgen, Inc. in the United States. The lawsuit alleges that Amgen has engaged in anticompetitive practices to hinder the entry of Sandoz’s biosimilar version of Enbrel® (etanercept), a medicine used to treat various inflammatory diseases.
Background
Enbrel®, first approved by the US Food and Drug Administration (FDA) in 1998, is a reference medicine for etanercept biosimilars. Sandoz’s biosimilar was approved by the FDA nearly a decade ago, but it has yet to reach the US market. The lawsuit claims that Amgen has taken various actions to delay the entry of Sandoz’s biosimilar, including paying large sums of money to keep pharmacy benefit managers from covering the biosimilar and engaging in patent infringement litigation.
Impact on Patients
The delay in the availability of the etanercept biosimilar has significant consequences for patients with disabling inflammatory diseases, such as rheumatoid arthritis, psoriasis, and ankylosing spondylitis. These conditions often require long-term treatment with expensive biologic medicines, and the high cost can be a barrier to access for many patients. The biosimilar version of etanercept, which is expected to be priced significantly lower than the reference medicine, could provide much-needed relief to these patients.
- Patients with inflammatory diseases may be able to access a more affordable treatment option
- The availability of a biosimilar may lead to increased competition in the market, potentially driving down prices for all etanercept products
Impact on the World
The lawsuit against Amgen by Sandoz could have far-reaching implications for the biopharmaceutical industry and healthcare systems around the world. If successful, the lawsuit could set a precedent for challenging anticompetitive practices that hinder the entry of biosimilars and other generic medicines.
- The outcome of this lawsuit could lead to increased competition in the biopharmaceutical industry, potentially driving down prices for innovative and generic medicines
- The success of Sandoz’s lawsuit could encourage other companies to challenge anticompetitive practices that hinder the entry of biosimilars and generic medicines
Conclusion
Sandoz’s decision to file an antitrust lawsuit against Amgen for delaying the entry of its etanercept biosimilar has significant implications for patients, the healthcare industry, and the biopharmaceutical industry as a whole. If successful, the lawsuit could lead to increased competition, potentially driving down prices for biologic medicines and increasing access to affordable treatments for patients with disabling inflammatory diseases.
The outcome of this lawsuit could also set a precedent for challenging anticompetitive practices that hinder the entry of biosimilars and generic medicines. As the global population ages and the need for affordable healthcare solutions grows, the importance of promoting competition in the pharmaceutical industry cannot be overstated.
We will continue to monitor this situation closely and provide updates as more information becomes available.
