On 12 August 2024, Amgen filed a lawsuit with the US District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics asserting infringement of 36 patents relating to denosumab. The BPCIA litigation reportedly follows the filing by Samsung Bioepis of an aBLA with the FDA for its biosimilar (SB16) to Amgen’s Prolia® and Xgeva® (denosumab).
This is the third BPCIA litigation filed by Amgen in relation to denosumab. In May 2024, Amgen filed a complaint against Celltrion alleging infringement of 29 patents relating to denosumab. That complaint remains pending. In May 2023, Amgen sued Sandoz in the US over its denosumab biosimilars (Jubbonti® and Wyost®) asserting infringement of 21 denosumab patents. That dispute was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances).