On 1 October 2025, Biocon announced that it has entered into a settlement and licence agreement with Amgen that resolves pending BPCIA patent litigation and permits Biocon’s 1 October 2025 US launch of Bosaya™ and Aukelso™ (denosumab-kyqq), biosimilars to Amgen’s Prolia® and Xgeva® respectively.
Amgen had filed the BPCIA litigation against Biocon on 30 June 2025 in the US District Court for the District of Massachusetts, Eastern Division, asserting infringement of 34 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.
The proceeding against Biocon was one of a number of proceedings that Amgen commenced in the US in relation to denosumab biosimilars, six of which have now settled (including the Biocon settlement):
- 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.
- Celltrion settled in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025.
- Accord and Intas settled US litigation with Amgen in July 2025, permitting launch of Accord/Intas’ denosumab biosimilar from 1 October 2025.
- Samsung Bioepis settled in early September 2025, with the terms of that settlement, including launch dates for Samsung Bioepis’ denosumab biosimilars, remaining confidential.
Amgen still has pending US denosumab litigation against Hikma/Gedeon Richter and Shanghai Henlius/Organon, which have had denosumab biosimilar applications accepted for review by the FDA.
Bosaya™ and Aukelso™ received FDA approval in September 2025 and were granted provisional interchangeability designation for all approved indications. They were the sixth pair of denosumab biosimilars to be approved in the US, following Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched). Richter/Hikma’s Enoby™ and Xtrenbo™ (denosumab qbde) were subsequently approved later in September 2025.