On 1 October 2025, Sandoz’s Erelzi®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in 50mg/mL syringe and pen devices.
Erelzi® is the third etanercept biosimilar to be PBS-listed (approved November 2017), following Biocon Biologics’ Nepexto® (July 2025 (auto-injector), approved September 2020 (PFS)) and Samsung Bioepis/Arrow Pharma’s Brenzys® (April 2017, approved July 2016). In August 2025, Biocon’s Nepexto® PFS presentation was recommended for PBS-listing (sponsor: Maxx Pharma).
In May 2022, Pfizer commenced Australian legal proceedings against Samsung Bioepis and other respondents (including MSD, Organon and Arrow Pharmaceuticals) alleging infringement of its Australian patent AU2005280034 relating to the production of etanercept. Samsung Bioepis and Organon cross-claimed, seeking to invalidate the patent. The hearing commenced on 1 September 2025 and is scheduled to conclude on 10 October 2025.
Etanercept has been the subject of various lawsuits in the US in recent years. In May 2025, a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws in relation to Enbrel® (etanercept) (and Otezla® (apremilast)), awarding Regeneron US$135.6 million in compensatory damages and $271.2 million in punitive damages.
In April 2025, Sandoz announced that it filed an antitrust lawsuit in the US District Court for the Eastern District of Virginia, 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®”. That litigation is ongoing.