Amgen and Celltrion Reach Settlement in Denosumab Patent Litigation, Paving Way for Mid-2025 Biosimilar Launch

Settlement Agreement:
Amgen and Celltrion have settled their patent infringement litigation related to denosumab biosimilars, allowing Celltrion to launch its products in the US starting June 1, 202534.

Patent Validation:
The settlement affirms the validity and enforceability of Amgen's patents covering denosumab, with Celltrion agreeing that its biosimilar products infringe these patents4.

Launch Plans:
Celltrion plans to launch its denosumab biosimilars in the US, Europe, and Japan in 2025, at a significant discount for osteoporosis prevention and treatment5.

Market Impact:
The settlement and upcoming launches are expected to impact the market for denosumab biosimilars, with Sandoz also scheduled to launch its denosumab biosimilars on May 31, 202523.

Legal Background:
The litigation was initiated by Amgen in May 2024, alleging infringement of 29 patents related to denosumab by Celltrion's biosimilar products34.

Sources:

2. https://biosimilarsrr.com/2025/01/03/whats-next-for-biosimilars-in-2025/

3. https://www.pearceip.law/2025/01/24/amgen-and-celltrion-settle-us-denosumab-litigation/

4. https://www.pearceip.law/wp-content/uploads/2025/01/Amgen-v-Celltrion-Consent-Judgment-and-Injunction-23-Jan-2025.pdf

5. https://www.pearceip.law/2025/01/20/celltrion-plans-2025-us-eu-jp-launch-of-biosimilar-denosumab-at-significant-discount-for-osteoporosis-prevention/