Sandoz, a global leader in generic pharmaceuticals and biosimilars, has officially filed an antitrust lawsuit in the United States against the biopharmaceutical giant Amgen. The lawsuit, lodged in the US District Court for the Eastern District of Virginia, challenges Amgen's allegedly anti-competitive practices surrounding its blockbuster drug, Enbrel (etanercept).

The core of Sandoz's lawsuit contends that Amgen has unlawfully extended its market exclusivity for Enbrel by purchasing and utilizing certain patent rights. This, they argue, has allowed Amgen to entrench its dominant position in the market, effectively delaying competition from biosimilar alternatives. One such alternative is Sandoz's own FDA-approved biosimilar, Erelzi (etanercept-szzs).

Erelzi was granted FDA approval in 2016 and subsequently launched in Europe the same year. However, despite its approval, it has yet to become available to patients in the United States due to ongoing patent disputes with Amgen. To address this situation, Sandoz is seeking an injunction that would prevent Amgen from continuing to block the entry of biosimilars into the US market. Additionally, they are pursuing treble damages under US antitrust law, which allows for triple the amount of damages to be awarded in cases where anti-competitive practices are proven.

Enbrel was one of the first biologics approved by the US Food and Drug Administration (FDA) in 1998, used primarily to treat autoimmune diseases like rheumatoid arthritis and psoriasis. By 2002, Enbrel had achieved blockbuster status, boasting global sales that surpassed the $1 billion mark. Recent revenue figures show that Enbrel generated an impressive $3.3 billion in the US alone in 2024.

When Erelzi received FDA approval in 2016, it found a more welcoming regulatory environment in Europe, which was more supportive of competition among biosimilars. However, despite its approval by the FDA, Sandoz has faced significant hurdles in launching Erelzi in the US due to Amgens existing patents, which are set to extend until 2029.

Sandoz has previously challenged the validity of these patents in court, but in a significant ruling in 2020, the US Court of Appeals for the Federal Circuit upheld Amgen's patents, siding with the biopharmaceutical company. Following this, Sandoz appealed to the US Supreme Court, but the court declined to hear the case in 2021, leaving Sandoz with limited options.

In its announcement on April 14, Sandoz argued that Amgen's continued market exclusivity is detrimental to the healthcare system, as it restricts access to more affordable treatment options for an estimated 7.5 million Americans suffering from chronic inflammatory conditions. The company emphasized that many of these patients could greatly benefit from the cost savings and increased access that would accompany the introduction of high-quality, more affordable biosimilar medications.

Experts have noted that the delayed entry of biosimilars into the US market is significantly influenced by complex patent disputes. For instance, AbbVies Humira (adalimumab) maintained its market exclusivity for two decades, even after its primary patent expired in 2016. AbbVie managed to secure over 100 additional patents and reached settlement agreements that postponed the launch of biosimilars until 2023, long after these alternatives had already entered the European market. Notably, Amgens own biosimilar version of Humira, known as Amjevita, was approved in 2016 but did not launch in the US until February 2023.