On January 23, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen and Celltrion resolving the BPCIA litigation regarding Celltrion's denosumab biosimilar, CT-P41. Pursuant to the agreement, Celltrion will be enjoined from making, using, selling, or importing CT-P41 into the U.S. market until June 1, 2025.
Celltrion submitted its BLA for CT-P41 to the FDA on November 30, 2023, referencing Amgen's PROLIA and XGEVA. Amgen filed suit against Celltrion on May 28, 2024, asserting 29 patents. In the Consent Judgment, Celltrion agreed that all 29 patents were valid, enforceable, and infringed.
CT-P41's BLA is still pending before the FDA. Meanwhile, Celltrion will begin to market its denosumab biosimilar in Korea during the first half of 2025.
This is the second settlement among Amgen's denosumab BPCIA litigations. Pursuant to Amgen's previous settlement with Sandoz in April 2024, Sandoz agreed to an injunction against Sandoz's WYOST (denosumab-bbdz) and JUBBONTI (denosumab-bbdz) products that expires next month, on February 19, 2025. WYOST and JUBBONTI were both approved by the FDA in March 2024, prior to the settlement. Under the terms of the settlement agreement, Sandoz may launch by May 31, 2025.
Three other denosumab BPCIA cases remain pending. Amgen filed complaints against Samsung Bioepis in the District Court for the District of Delaware on August 12, 2024 regarding biosimilar SB16, against Fresenius Kabi in the District Court for the Northern District of Illinois on October 4, 2024 regarding biosimilar FKS518, and against Accord Biopharma in the District Court for the Eastern District of North Carolina on November 13, 2024 regarding biosimilar INTP23.
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