- Sandoz (SIX:SDZ/OTCQX:SDZNY) has filed an antitrust lawsuit against Amgen regarding patent-related market obstacles for its etanercept biosimilar, Erelzi®.
- The lawsuit could potentially unlock a $3.3 billion market in the US for biosimilar treatments.
- Approximately 7.5 million US patients with chronic inflammatory diseases stand to benefit from more affordable treatment options.
Sandoz, the global leader in generic and biosimilar medicines, has initiated an antitrust lawsuit against Amgen, Inc. in the US District Court for the Eastern District of Virginia. The case challenges Amgen's alleged misuse of patent rights to maintain dominance over the market for Enbrel® (etanercept), which generated USD 3.3 billion in US revenue in 2024.
Despite receiving FDA approval in 2016, Sandoz's biosimilar, Erelzi®, has been unable to enter the US market due to Amgen's patent strategies. The lawsuit seeks an injunction to prevent Amgen from using specific patent rights that block competition and aims to clear the way for Sandoz to launch Erelzi® in the United States. If successful, the lawsuit could allow for tripled damages under relevant antitrust laws.
The potential introduction of Erelzi® into the US market could significantly benefit around 7.5 million Americans suffering from chronic inflammatory diseases, including rheumatoid arthritis and psoriasis, by providing more affordable treatment alternatives. This antitrust move underscores Sandoz's commitment to expanding patient access to high-quality biosimilar options.
