On 20 January 2025, Korea Biomedical Review reported that, at the JP Morgan Healthcare Conference on 14 January 2025, Celltrion revealed its plans to launch CT-P41, biosimilar to Amgen’s Prolia® (denosumab) in the US, Europe and Japan in 2025, at a significant discount for the prevention of osteoporosis as well as its treatment.
Celltrion filed an abbreviated Biologics Licence Application for CT-P41 in the US in December 2023. However, in May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab. That litigation remains pending as at the date of Celltrion’s announcement at the JP Morgan Conference.
Celltrion’s Osenvelt®/CT-P41, biosimilar to Amgen’s Xgeva® (denosumab), and Stoboclo®/CT-P41, biosimilar to Amgen’s Prolia® (denosumab), received positive opinions from the EMA’s CHMP in December 2024.
According to KBM, at the JP Morgan Conference, Celltrion’s Chairman also revealed that the company plans to launch four other biosimilars in the US, EU and Japan in 2025: ustekinumab/Steqeyma®/CT-P43 (already launched in Europe in November 2024, approved in US in December 2024); aflibercept/Eydenzelt™/CT-P42 (NDA filed with the FDA in June 2023, positive CHMP opinion received from the European Medicines Agency in December 2024); tocilizumab/Avtozma®/CT-P47 (positive CHMP opinion received in December 2024; BLA submitted in the US in January 2024); omalizumab/Omlyclo®/CT-P39 (approved in Europe (May 2024) and aBLA submitted in the US in March 2024).