On 25 July 2024, Bio-Thera announced commencement of an integrated Phase I/III trial for its BAT3306, biosimilar to MSD’s Keytruda® (pembrolizumab), in non-squamous, non-small cell lung cancer (nsNSCLC). The study will compare the pharmacokinetics, efficacy and safety of BAT3306 with Keytruda®.
Other pembrolizumab biosimilars in clinical trials are Formycon’s FYB206 (Ph I commenced in June 2024 for malignant melanoma; Ph 3 planned for NSCLC), Amgen’s ABP 234 (Ph 3 study in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 study for metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 and 3 clinical trials 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. Xbrane and Celltrion have also each previously announced a joint pembrolizumab biosimilar development.