On 12 August 2024, Celltrion announced that the FDA has approved its phase 3 clinical trial plan for CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab). The global phase 3 trial will evaluate the effectiveness of CT-P51 and its and equivalence with Keytruda® in patients with metastatic non-small cell lung cancer (NSCLC).
A number of other pembrolizumab biosimilars have entered clinical trials this year, including Formycon’s FYB205 (Ph 3 in NSCLC commenced 30 July 2024; Ph I in malignant melanoma commenced June 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced 25 July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 and 3 commenced in April/May 2024). In March 2024, Korea Biomedical Review reported that Rophibio entered into an agreement with US biotech Avantor in relation to the development of a pembrolizumab biosimilar.