On 23 July 2025, Biocon Biologics announced that it has launched Nepexto®, biosimilar to Amgen/Pfizer’s Enbrel® (etanercept), in Australia. Nepexto® was approved by Australia’s Therapeutic Goods Administration in September 2022, and will be supplied by Biocon’s local partner, Lupin (Generic Health).
In June 2025, we reported that Nepexto®, among other biosimilars, was positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS). Nepexto® became the second etanercept biosimilar to be PBS-listed as of 1 July 2025, following Samsung Bioepis/Arrow Pharma’s Brenzys® in April 2017.
In May 2022, Pfizer commenced Australian proceedings against Samsung Bioepis and other respondents (including MSD, Organon and Arrow Pharmaceuticals) for alleged 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 is scheduled to commence on 1 September 2025.
Etanercept has been the subject of various lawsuits in the United States 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.