In April 2024, we reported that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), and published those results in late July. On 18 November 2024, Celltrion presented additional data from that trial. Celltrion has also presented additional data from a Phase 3 trial of CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), which follows encouraging findings in June 2024.
Results from week 52 to week 78 data showed comparable and sustained efficacy results to reference denosumab in treating postmenopausal women with osteoporosis after switching to CT-P41. One-year results of CT-P47 supported biosimilarity to reference tocilizumab, demonstrating comparable and sustained efficacy, safety and immunogenicity profiles in patients with active moderate-to-severe rheumatoid arthritis.
This news follows the October 2024 announcement of a joint sales agreement between Celltrion and Daewoong Pharmaceutical under which the two companies will jointly promote CT-P41 in Korea. Celltrion filed an aBLA for CT-P41 in the US in December 2023 and, in May 2024, was sued by Amgen in the US District Court of New Jersey for alleged infringement of 29 patents regarding denosumab. That litigation is ongoing.