Amgen Update on Patent Litigation Related to Sandoz Denosumab Biosimilar Products
We are pleased to have reached resolution of our patent infringement litigation related to Sandoz’s denosumab biosimilar products. By court order issued today (April 29), the asserted claims of Amgen’s U.S. Patent No. 7,364,736 are valid, enforceable and infringed by Sandoz's denosumab biosimilars in the United States. In addition, Amgen and Sandoz have reached a confidential settlement that resolves the remaining patent disputes in the lawsuit and allows Sandoz to launch its biosimilar products on May 31, 2025, or earlier under certain limited conditions. Specific financial terms remain confidential.
This settlement and court decision affirm the strength of Amgen's patent rights for denosumab. Amgen remains confident in the proven benefits of Prolia® (denosumab) for millions of patients worldwide with osteoporosis and other bone loss conditions and XGEVA® (denosumab) for patients with multiple myeloma or bone metastases from certain types of cancer. We are committed to continuing to provide and maintain access for these important medicines, while vigorously defending our patent rights.