As reported in April this year, Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), at the World Congress on Osteoporosis held in London from 11-14 April 2024. On 6 August 2024, Celltrion announced that the results were published in Osteoporosis International in late July.
The study relates to a 78-week Phase 3 clinical trial in which the primary efficacy and pharmacodynamic endpoints between CT-P41 and denosumab were found to be equivalent.
After filing its US aBLA for CT-P41 in December 2023, Celltrion was sued by Amgen in the District Court of New Jersey on 28 May 2024 for infringement of 29 patents regarding denosumab. 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).