On March 7, 2025, the District Court for the District of New Jersey entered a Stipulation and Order of Dismissal Without Prejudice in view of a settlement agreement between Amgen and Fresenius Kabi resolving the BPCIA litigation regarding Fresenius’s denosumab biosimilar, FKS518. The Order followed a stipulation by the parties filed on March 4, 2025.
The FDA accepted Fresenius’s BLA for its denosumab biosimilar on May 27, 2024. On October 4, 2024, Amgen filed its Complaint against Fresenius in the District Court for the Northern District of Illinois Eastern Division. The case was then transferred to the District Court for the District of New Jersey “for coordinated or consolidated pretrial proceedings,” pursuant to an order on Feb. 6, 2025 from the U.S. Judicial Panel for Multidistrict Litigation.
In a related matter, Amgen recently issued a subpoena to HyClone Laboratories, LLC, a cell culture media supplier. Amgen has since withdrawn its subpoena in view of the underlying settlement.
This is the third settlement among Amgen’s denosumab BPCIA litigations, following Amgen’s settlements with Sandoz in April 2024 and Celltrion in January 2025.
Two other denosumab BPCIA cases remain pending. Amgen filed complaints against Samsung Bioepis in the District Court for the District of New Jersey on Aug. 12, 2024, and against Accord Biopharma in the District Court for the Eastern District of North Carolina on Nov. 13, 2024. The case against Accord Biopharma was also transferred on Feb. 6, 2025 for consolidated pre-trial proceedings, pursuant to the order from the U.S. Judicial Panel on Multidistrict Litigation.
Stay tuned to Big Molecule Watch as we continue to monitor key developments in ongoing denosumab litigations and the biosimilars market.