On 25 June 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Hikma Pharmaceuticals/Gedeon Richter and Shanghai Henlius Biotech/Organon, asserting infringement of multiple US patents (32 for Hikma/Richter and 26 for Henlius/Organon) covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.
The litigation follows the FDA’s acceptance in December 2024 of Richter/Hikma’s BLA for RGB-14-P and RGB-14-X, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab). Under an exclusive licence agreement entered in December 2021, Gedeon Richter is responsible for the development of RGB-14, while Hikma is responsible for FDA registration and has exclusive rights to commercialise it in the US following approval.
Organon and Shanghai Helius’ BLA for HLX14 (denosumab) was accepted for review by the FDA in October 2024. In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 (and pertuzumab, HLX11) under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.
The complaints against Hikma/Richter and Henlius/Organon represent the 6th and 7th BPCIA suits filed by Amgen in the US in relation to alleged patent infringement concerning denosumab biosimilars. However, Amgen has settled three of its US denosumab disputes over the last 18 months. A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, in the US from 31 May 2025. Amgen settled its US litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025. In March 2025, Amgen entered into a global settlement of its patent infringement litigation in relation to Fresenius Kabi’s denosumab biosimilar, allowing US launch of Fresenius’ biosimilar in mid-2025. Amgen’s BPCIA litigation against Accord/Intas and Samsung Bioepis regarding their denosumab biosimilars remains pending.