Sandoz has initiated an antitrust lawsuit against Amgen in the United States, alleging that the latter has engaged in anti-competitive practices to maintain its dominance in the market for the biologic drug Enbrel (etanercept). The lawsuit, filed in the US District Court for the Eastern District of Virginia, claims that Amgen has unlawfully acquired and utilized specific patent rights to prolong its market exclusivity, thereby hindering the entry of biosimilar competitors, including Sandoz's own FDA-approved biosimilar, Erelzi (etanercept-szzs). Despite receiving FDA approval in 2016 and launching in Europe in 2017, Erelzi has not been made available to patients in the US due to ongoing patent conflicts. Sandoz is now seeking a court injunction to stop Amgen from obstructing the introduction of biosimilars and is also pursuing treble damages under US antitrust legislation. Enbrel, which was first approved by the FDA in 1998 for treating autoimmune diseases such as rheumatoid arthritis and psoriasis, achieved blockbuster status by 2002, generating $3.3 billion in US sales in 2024. Sandoz has previously contested the validity of Amgen's patents, but in 2020, the US Court of Appeals upheld these patents, a decision that was later declined for review by the US Supreme Court in 2021. Sandoz argues that Amgen's sustained market exclusivity adversely affects the healthcare system by restricting access to affordable treatment options for approximately 7.5 million Americans suffering from chronic inflammatory conditions. Analysts note that the protracted delays in biosimilar market entry in the US are primarily due to intricate patent disputes, which have historically allowed companies like AbbVie to extend their product exclusivity significantly beyond the original patent expiration.
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