On 13 March 2026, Sandoz filed an appeal with the US Court of Appeals for the Fourth Circuit, challenging the dismissal of the antitrust proceeding it had commenced in April 2025 alleging that Amgen “unlawfully extended and entrenched its monopoly” for Enbrel® by “blocking competition from more cost-effective biosimilar competitors, including Sandoz’s etanercept biosimilar, Erelzi®”.
The US District Court for the Eastern District of Virginia dismissed Sandoz’s antitrust claim on 17 February 2026, and entered judgment in favour of Amgen. It is this judgment from which Sandoz now appeals.
Sandoz’s complaint relates to Amgen’s purchase of exclusive US rights to certain etanercept-related patents owned by Roche (referred to as the Brockhaus Patents). According to Sandoz, the purchase of those rights was anti-competitive, as was Amgen’s use of certain Brockhaus Patents (US 8,063,182 and US 8,163,522, having a latest expiry date in 2029) to “eliminate competition in the US etanercept market by blocking biosimilar entrants, including Sandoz”.
Amgen commenced BPCIA litigation against Sandoz in February 2016, including for infringement of the ‘182 and ‘522 patents. Erelzi® was FDA approved in August 2016. The ‘182 and ‘522 patents were held to be valid and infringed, and Sandoz was prevented from launching Erelzi® in the US by way of an injunction that remains in place until 2029. In the antitrust litigation, Sandoz argues that “were it not for Amgen’s unlawful acquisition” of the Brockhaus Patents, Sandoz “would have launched its etanercept biosimilar in the US at least as early as 2019” (when certain Amgen patents expired).
The only other etanercept biosimilar approved in the US is Samsung Bioepis’ Eticovo® (April 2019). Samsung Bioepis is prevented from launching Eticovo® in the US until 2029 by a permanent injunction granted in November 2021.
Etanercept biosimilars have been launched in other jurisdictions, including the UK (e.g. Samsung Bioepis’ Benepali® in February 2016), Europe (e.g. Biocon/Lupin’s Nepexto® in August 2020) and Canada (e.g. Sandoz/Lupin’s Rymti® in May 2024). There are multiple etanercept biosimilars in the Australian market listed on the PBS, including Sandoz’s Erelzi® (approved November 2017, PBS-listed as of October 2025), Biocon Biologics’ Nepexto® (launched in July 2025, PBS-listed as of July 2025) and Samsung Bioepis’ Brenzys®, which was previously distributed in Australia by Arrow Pharmaceuticals (approved by TGA in July 2016, PBS-listed as of April 2017). However, judgment in an Australian patent infringement proceeding brought by Pfizer in relation to Samsung Bioepis’ Brenzys®, heard in September/October 2025, is yet to be delivered.