Sandoz has filed an antitrust lawsuit in the US against Amgen, challenging alleged anti-competitive practices surrounding the biologic blockbuster Enbrel (etanercept).
Filed at the US District Court for the Eastern District of Virginia, the suit contends that Amgen extended its market exclusivity for Enbrel by “unlawfully purchasing and using certain patent rights to entrench its position in the market”. Sandoz said this is delaying competition from biosimilar alternatives – including its own US Food and Drug Administration (FDA)-approved biosimilar Erelzi (etanercept-szzs).
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Although Erelzi was FDA-approved in 2016 and launched in Europe in 2017, it has yet to reach US patients due to ongoing patent disputes. Sandoz is now seeking an injunction to prevent Amgen from continuing to block biosimilar entry and is also pursuing treble damages under US antitrust law.
Approved in 1998, Enbrel was one of the first US Food and Drug Administration (FDA) approved biologics for autoimmune diseases like rheumatoid arthritis and psoriasis. By 2002, it had achieved blockbuster status, having surpassed the $1bn sales mark globally. Enbrel generated $3.3bn in US revenue in 2024.
When Erelzi was approved in 2016, it launched in Europe where the biosimilar regulatory environment was more favourable and supportive of competition. Despite FDA approval, Sandoz was blocked from launching Erelzi in the US due to Amgen’s patents, which extend into 2029.
Sandoz has previously challenged the validity of these patents in court. However, in 2020, the US Court of Appeals for the Federal Circuit upheld Amgen’s patents, ruling in its favour. Sandoz appealed to the US Supreme Court, which declined to hear the case in 2021.
Sandoz argues that continued market exclusivity harms the healthcare system by limiting access to more affordable treatment options for an estimated 7.5 million Americans living with chronic inflammatory conditions. In the 14 April announcement, Sandoz states that many of these patients could benefit from the cost savings and expanded access resulting from the introduction of high-quality, more affordable biosimilar options.
Delayed biosimilar market entry in the US is largely driven by complex patent disputes, according to GlobalData analyst Cyrus Fan. AbbVie’s Humira (adalimumab) maintained exclusivity for two decades despite the main patent expiring in 2016. AbbVie secured over 100 additional patents and reached settlement agreements that delayed biosimilar launches until 2023 – years after biosimilars entered the European market. The first US biosimilar, Amgen’s Amjevita (adalimumab), was approved in 2016 but only launched in the US in February 2023.
Fan added: “The US biosimilar market is notably underdeveloped and biosimilar entry in the US has been difficult, consistently lagging behind Europe.”
GlobalData is the parent company of Pharmaceutical Technology.
Paragraph 3 was updated to change the European launch year to 2017 from 2016.
