On 6 February 2025, the US Judicial Panel on Multijurisdictional Litigation granted Amgen’s request to centralise its BPCIA litigation alleging that each of Samsung Bioepis, Fresenius Kabi and Accord Biopharma are infringing US patents covering Amgen’s Prolia® and Xgeva® (denosumab). The Panel ruled that each of the lawsuits involve “common issues of fact and law” and should be transferred to the US District Court for the District of New Jersey. This was because Amgen had previously commenced three denosumab actions in that jurisdiction and the New Jersey Judge hearing the matters was familiar with the issues.
Amgen commenced the proceedings against Samsung Bioepis in August 2024 (District of New Jersey), Fresenius Kabi in October 2024 (Northern District of Illinois) and Accord Biopharma in November 2024 (Eastern District of North Carolina) in respect of Biologics Licence Applications filed for denosumab biosimilars SB16, FKS518 and INTP23, respectively.
A dispute with Sandoz, commenced by Amgen in May 2023 in the US District Court for the District of New Jersey, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, from 31 May 2025 (or earlier in certain undisclosed circumstances). On 24 January 2025, Amgen announced that it had settled its patent infringement litigation against Celltrion in the US District Court for the District of New Jersey, relating to Celltrion’s biosimilar denosumab CT-P41. An injunction, granted by consent, preventing Celltrion from launching CT-P41 in the US expires on 1 June 2025, permitting US launch of Celltrion’s denosumab biosimilars from that date.
Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024. No other denosumab biosimilars have been approved in the US to date, although a number of applicants have had applications accepted for review by the FDA, including: Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024).