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Accord/Intas’ Biosimilar Denosumab Set for Oct 2025 US Launch Following Settlement with Amgen

Jul 16, 2025

On 16 July 2025, the US District Court for the District of New Jersey made consent orders reflecting a settlement of the patent infringement litigation brought by Amgen against Accord and Intas relating to Accord/Intas’ biosimilar denosumab.  While the terms of the settlement agreement are confidential, the consent orders restrain Accord/Intas from launching biosimilar denosumab in the US until 1 October 2025.

Amgen commenced BPCIA proceedings against Accord/Intas in November 2024, alleging infringement of 34 of Amgen’s US patents relating to denosumab and methods of its manufacture.  The litigation followed Accord/Intas’ submission of an abbreviated Biologics Licence Application (aBLA) for INTP23, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

The proceeding against Accord/Intas was one of a number of proceedings that Amgen commenced in the US in relation to denosumab biosimilars, three of which have now settled.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, with Sandoz launching its denosumab biosimilars, Jubbonti® and Wyost®, in June 2025.  Fresenius Kabi launched Conexxence® and Bomyntra® in early July 2025, following a global settlement agreement with Amgen, resulting in the dismissal of US BPCIA litigation commenced by Amgen in October 2024.  Amgen and Celltrion also settled their BPCIA litigation in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025.

Amgen still has pending US denosumab litigation against Hikma/Gedeon Richter, Shanghai Henlius/Organon, and Biocon, which have all had denosumab biosimilar applications accepted for review by the FDA.