On 22 November 2024, Celltrion announced that the Korean Ministry of Food and Drug Safety has approved its Stoboclo™ (CT-P41, denosumab) and Osenvelt™ (CT-P41, denosumab), biosimilars to Amgen’s Prolia® and Xgeva®, respectively.
Stoboclo™ and Osenvelt™ are the first denosumab biosimilars to be approved in Korea and are approved for all indications of the reference medicines.
Celltrion entered into a joint sales agreement with Daewoong Pharmaceutical in October 2024 under which the two companies will jointly promote Celltrion’s denosumab biosimilars in Korea. According to Daewoong Pharmaceutical, CT-P41 is scheduled to be launched in the first half of 2025 in Korean hospitals and clinics.
In December 2023, Celltrion filed an abbreviated Biologics Licence Application for CT-P41 (denosumab biosimilar to Prolia®) in the US. In May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab. US litigation regarding denosumab biosimilars is also pending against Fresenius Kabi (FKS518/commenced October 2024), Samsung Bioepis (SB16/commenced August 2024), and Accord/Intas (INTP23, November 2024). An earlier dispute between Amgen and Sandoz was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars Jubbonti® and Wyost® in the US from 31 May 2025 (or earlier in certain undisclosed circumstances).