Arthritis drug: Sandoz files US antitrust litigation against Amgen

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 USD 3.3 billion in revenue in the US.

Sandoz received US FDA approval for Erelzi in 2016, the same year the company launched the medicine in Europe. 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 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.

Erelzi is the Sandoz biosimilar of the reference medicine Enbrel. Erelzi has been studied in a global development program, which included a comprehensive comparison of Erelzi and Enbrel at the analytical, preclinical, and clinical levels. The program included preclinical studies, pharmacokinetic (PK) studies, and the Phase III confirmatory safety and efficacy EGALITY study. Erelzi is approved by the US FDA for the following indications: adult rheumatoid arthritis (RA), ankylosing spondylitis (AS), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA) and moderate to severe plaque psoriasis (PsO).