On 13 November 2024, Amgen filed a BPCIA Complaint for Patent Infringement in the US District Court for the Eastern District of North Carolina against Accord Biopharma, Accord Healthcare and Intas Pharmaceuticals. The Complaint asserts infringement of 34 of Amgen’s US patents relating to denosumab and methods of its manufacture.
The litigation follows Accord/Intas’ submission of an abbreviated Biologic Licence Application (aBLA) to the FDA for INTP23, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).
This is the fifth BPCIA litigation filed by Amgen in relation to denosumab, following actions against Fresenius Kabi (FKS518/commenced October 2024), Samsung Bioepis (SB16/commenced August 2024), Celltrion (CT-P41/commenced in May 2024) and Sandoz (Jubbonti®/Wyost®/commenced in May 2023). Amgen’s dispute with Sandoz 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). The other disputes remain pending.
On 18 November 2024, Amgen filed a motion seeking to transfer all four pending actions to the District of New Jersey so that they may be heard together.
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, although Fresenius Kabi’s BLA for its denosumab biosimilar (FKS518) was accepted in May 2024, Teva’s BLA for TVB-009P (denosumab) was accepted in October 2024 and Organon/Shanghai Henlius’ BLA for HLX14 (denosumab) was accepted in late October 2024.