Sandoz files antitrust litigation against Amgen regarding entanercept biosimilar

Sandoz has filed an antitrust lawsuit in the United States against Amgen, for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept). The drug was first approved by the Food and Drug Administration in 1998.

Etanercept is a biologic medicine used to treat a range of disabling inflammatory diseases. Sandoz alleges that Amgen blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi+ (etanercept-szzs), by unlawfully purchasing and using certain patent rights to entrench its position in the market. In 2024, Enbrel generated $3.3 billion in revenue in the United States.

[Read more: Sandoz takes further steps to resolve legacy U.S. Generic Drug Antitrust Class Action litigation]

Sandoz received FDA approval for Erelzi in 2016.

Sandoz said, "Today, Amgen is continuing to block entry of this important treatment option for approximately 7.5 million Americans living with chronic inflammatory diseases, including rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis, many of whom could benefit from the cost savings and expanded access resulting from the introduction of high-quality, more-affordable biosimilar options."

Sandoz is seeking an injunction to prevent Amgen from using certain patent rights to block biosimilar competition and allow Sandoz to launch Erelzi as soon as possible. The company also is seeking damages, which could be tripled under applicable laws. The lawsuit was filed in the U.S. District Court for the Eastern District of Virginia.

[Read more: A new environment for biosimilars]