Sandoz Files Antitrust Suit Against Amgen
Sandoz, a global leader in generic and biosimilar medicines announced the filing of an antitrust lawsuit in the US against Amgen Inc. for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the FDA in 1998
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 USD 3.3 billion in revenue in the US. Sandoz received US FDA approval for Erelzi in 2016. Currently 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 and psoriasis.
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 is also seeking damages, which could be tripled under applicable laws. The lawsuit was filed in the US District Court for the Eastern District of Virginia.