Despite FDA approval nearly a decade ago, etanercept biosimilar continues to be blocke
Sandoz , the global leader in generic and biosimilar medicines, announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel® (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998.
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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.
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Sandoz received US FDA approval for Erelzi® in 2016, the same year the company launched the medicine in Europe. 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[2-6], 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.
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Source – PR Newswire
